LEGAL

FULL DISCLOSURES

This Legal Disclaimer ("Disclaimer") governs the purchase and use of all medical devices manufactured or distributed by Pulse Wave, and their respective parent companies, affiliates, subsidiaries, officers, directors, employees, and agents (collectively, "Manufacturer" or "Company"). The medical device(s) subject to this Disclaimer are referred to herein as the "Device." By purchasing or using the Device, the Purchaser agrees to be legally bound by all terms and conditions set forth in this Disclaimer and all accompanying product documentation, operator manuals, and guidelines.

1.  AUTHORIZED PURCHASERS

All purchases of the Device are expressly limited to properly licensed medical professionals. By completing a purchase, the Purchaser represents and warrants that they: (a) hold a current, valid, and unrestricted professional license in their applicable jurisdiction; (b) are legally authorized under all applicable federal, state, and local laws and regulations to acquire, possess, operate, and use the Device; and (c) have confirmed that the therapeutic use of the Device falls within their defined scope of practice as established by their relevant licensing authority and applicable professional standards.

2.  INSURANCE REQUIREMENTS

As a condition of purchase and continued use of the Device, the Purchaser is required to maintain at all times adequate and current: (a) medical malpractice insurance; and (b) commercial general liability insurance, in amounts appropriate for their practice, patient population, and jurisdiction. The Company reserves the right to request written proof of such coverage at any time. Failure to maintain required insurance does not diminish or transfer any obligation or liability of the Purchaser.

3.  PROHIBITED USES AND WARRANTY CONDITIONS

The Device is intended solely for uses expressly described in the accompanying product documentation, operator manual, and approved labeling. Any use not explicitly authorized therein — including any off-label use — is strictly prohibited and will immediately void all applicable warranties. The following events each constitute a warranty-voiding occurrence:

(a)  Use for any purpose not explicitly described in the operator manual or approved product documentation;

(b)  Any impact, drop, or physical shock event after delivery, whether or not reported. Each unit is equipped with drop-detection sensors, and any unregistered drop event constitutes a warranty-voiding occurrence;

(c)  Operation without the Company-provided surge protector or with any unauthorized surge protection device; and

(d)  Any modification, unauthorized repair, or service by parties not expressly authorized in writing by the Company.

The Company expressly disclaims all liability for damages, injuries, or adverse outcomes resulting from use outside specified and approved operating parameters.

4.  LIMITATION OF LIABILITY AND RELEASE

To the fullest extent permitted by applicable law, by purchasing the Device, the Purchaser agrees to release, indemnify, defend, and hold harmless the Company, its affiliates, parent companies, subsidiaries, officers, directors, employees, agents, and distributors from and against any and all claims, demands, damages, losses, costs, and expenses (including reasonable attorneys' fees) arising out of or related to:

(a)  Use of the Device outside its specified operating parameters or approved indications;

(b)  Misuse, unauthorized use, or use inconsistent with provided instructions and documentation;

(c)  Failure to adhere to prescribed power-to-frequency ratios or other operating parameters;

(d)  Improper care, handling, storage, or maintenance of the Device;

(e)  Patient injury resulting from use outside operational guidelines; or

(f)  Use by an operator who has not received proper training or appropriate supervision.

The Purchaser bears sole responsibility for ensuring that any individual authorized to operate the Device has received proper training and is supervised by a licensed provider. The Purchaser bears sole responsibility for: (a) ensuring that any individual authorized to operate the Device has received proper training and is supervised by a licensed provider at all times; (b) independently evaluating and confirming that each patient or individual upon whom the Device is to be used is an appropriate clinical candidate for treatment, including screening for all contraindications identified in the operator manual and applicable clinical guidelines; and (c) ensuring that all use of the Device is performed exclusively within the Purchaser's defined scope of practice as established by their applicable licensing authority, strictly in accordance with the Device's described and approved indications for use, and in full compliance with all applicable federal, state, and local laws and regulations. Any use of the Device for purposes not explicitly described in the operator manual or approved product documentation — including any off-label application — is strictly prohibited, constitutes a material breach of this Agreement, and shall be the sole liability of the Purchaser.

5.  INSTRUCTIONAL MATERIALS AND OPERATOR RESPONSIBILITY

All instructional materials, operator manuals, and guidelines provided by the Company are incorporated herein by reference and are deemed to have been read, understood, and accepted by the Purchaser upon receipt of the Device. The Purchaser expressly agrees to comply fully with all instructions prior to and during operation. The Company disclaims all responsibility for any injury, damage, or adverse outcome resulting from failure to follow provided instructions.

6.  ACKNOWLEDGMENT AND AGREEMENT

By purchasing and using the Device, the Purchaser expressly acknowledges that they have read, understood, and agree to be legally bound by all terms and conditions of this Disclaimer, as well as all accompanying instructional materials and product documentation. This acknowledgment is a material condition of the purchase and continued use of the Device.

7.  REGULATORY STATUS, DEVICE CLASSIFICATION, AND CLAIMS

The Company is an FDA-Registered Medical Device Establishment, maintaining current and active registration status in accordance with 21 C.F.R. Part 807. This registration status does not constitute FDA clearance, approval, or individual device evaluation, and no such implication is intended or should be inferred.

The Device is classified as a low-intensity extracorporeal shockwave therapy device. Consistent with current FDA regulatory policy, Class I medical devices are not required to obtain individual 510(k) clearance, provided the Company maintains valid FDA Establishment Registration in the United States. This statement is for informational purposes only and does not constitute a claim of FDA clearance or approval for any specific indication.

(a)The Company does not claim that the Device can cure, treat, mitigate, or prevent any disease, disorder, or medical condition. Any references to musculoskeletal conditions are provided solely as educational reference material for licensed medical professionals and have not been individually evaluated or approved by the FDA. Such references do not constitute medical advice.

(b)CONTRAINDICATIONS: The Company makes no claims, express or implied, with respect to any currently registered intellectual property, patents, patented protocols, method patents, process patents, or proprietary treatment methodologies owned or controlled by any third party, and nothing in this Agreement or any accompanying materials shall be construed as a license to or endorsement of any such intellectual property. The Device is cleared solely for the indications and applications expressly recognized under current applicable FDA regulations and clearances, and shall not be used on any tissue, structure, organ, or anatomical region that is not explicitly covered by such clearances. Any use of the Device outside its current FDA-recognized indications — including but not limited to applications involving tissues, structures, conditions, or patient populations not clinically indicated under applicable regulatory clearances — is strictly contraindicated and constitutes a prohibited off-label use. The Company makes no claims regarding any biological mechanism, cellular response, physiological effect, or therapeutic outcome beyond those recognized within the Device's current regulatory status, and expressly disclaims any representation regarding the effect of the Device on any cellular, molecular, or biological process whether or not such mechanisms have been described in third-party scientific literature.

(c)The reference of terms including “Designed & Engineered In The U.S.”, "Manufactured in the USA" and "Assembled in the USA" refer to devices assembled at the Company’s U.S. facility using components sourced both domestically and internationally. All design, engineering, final assembly, testing, service, warranty administration, and repair are performed at the Company’s U.S. facility.

(d)NCMIC Vendor Partnership: The Company holds a vendor partnership with NCMIC. NCMIC is a registered trademark of NCMIC Group, Inc. This reference does not constitute an endorsement by NCMIC of any specific product, claim, or treatment. 

(e)CE credit claims may not be applicable in all U.S. states; contact support to verify applicability in your jurisdiction. 

(f)Certain technical specifications may be extrapolated from established comparative values where direct measured data are not independently available. 

(g)All proprietary materials, schematics, and educational content are protected by applicable intellectual property law. Unauthorized use or distribution is strictly prohibited.

8.  CGI AND IMAGERY DISCLAIMER

Certain images in Company marketing materials and product documentation have been created or enhanced using Computer-Generated Imagery (CGI) to illustrate detail, three-dimensional structure, or internal components. Internal components may be enlarged for clarity. Visual representations may not precisely reflect the actual appearance, proportions, color, or dimensions of the physical product. All images are protected under applicable copyright and trademark law. Unauthorized use, reproduction, or distribution is strictly prohibited.

9.  PROPRIETARY TECHNOLOGY AND INTELLECTUAL PROPERTY PROTECTION

All hardware, firmware, software, schematics, designs, protocols, and technical specifications incorporated in or associated with the Device constitute proprietary and trade secret information of the Company. Each purchase constitutes the Purchaser's agreement that the Device is acquired solely for authorized clinical use and not for disassembly, reverse engineering, or competitive analysis.

The following conduct is expressly prohibited: (a) disassembly, reverse engineering, or any attempt to derive the design or specifications of the Device; (b) unauthorized access to or copying of firmware, software, schematics, or proprietary documentation; (c) procurement on behalf of or with intent to transfer to a competitor; and (d) any attempt to solicit or exploit patent-pending or trade secret information. Such conduct may constitute violations of the Defend Trade Secrets Act (18 U.S.C. § 1836 et seq.), the Economic Espionage Act (18 U.S.C. §§ 1831–1839), and the Computer Fraud and Abuse Act (18 U.S.C. § 1030). The Company reserves all rights to pursue all available civil and criminal remedies.

10.  THIRD-PARTY EDUCATIONAL PROVIDERS

Shockwave University™ is an independent, third-party accredited educational platform.

© 2026 Pulse Wave USA. All Rights Reserved. Version 8.0 enacted April 17, 2026.