LEGAL

This legal disclaimer ("Disclaimer") applies to the purchase and use of any medical device manufactured or distributed by SHOCKWAVE PRO USA LLC, Pulse Wave, Asclepius Medical Holdings LLC ("Manufacturer").

1. Authorized Purchasers

Purchases of any medical device from SHOCKWAVE PRO USA LLC, Pulse Wave, Asclepius Medical Holdings LLC ("Device") are strictly limited to properly licensed medical professionals. By purchasing a Device, the purchaser ("Purchaser") affirms that they are a licensed medical professional with the authority to operate and use such medical equipment in accordance with applicable laws and regulations.

2. Insurance Requirements

The Purchaser is required to maintain proper and adequate medical malpractice insurance and commercial liability insurance at all times during the possession and use of the Device. Proof of such insurance may be requested by the Manufacturer at any time.

3. Prohibited Uses and Warranty Voiding

The use of the Device for any unspecified or off-label purposes is strictly prohibited. Any such use will immediately void the warranty provided by the Manufacturer. The Manufacturer shall not be held liable for any damages, injuries, or other consequences arising from the use of the Device outside of the specified and approved operating parameters as outlined in the product documentation. Any use outside that described in the operating manual will be considered a warranty voiding event. A DROP event after receipt of the unit is a warranty voiding event. Each unit is equipped with DROP sensors and any DROP that is not reported is a warranty voiding event. Use of this unit with out the provided surge protector or use without a surge protector is a warranty voiding event.

4. Release of Liability

By purchasing the Device, the Purchaser releases SHOCKWAVE PRO USA LLC from any and all liability related to the use of the Device outside of any and all listed and specified operating parameters. The Manufacturer is not responsible for any misuse, unauthorized use, or use that is inconsistent with the instructions and guidelines provided with the Device. By purchasing this device the purchaser releases this company and the manufacturer of any and all liability related to injury of a patient during the use of the machine outside of any and all operational instructions and guidelines. Including power to frequency ratio, improper care or maintenance of the machine. It is the purchasers duty to ensure any authorized user utilizing the device has been properly trained and must be supervised by the provider.

5. Instructional Materials

All instructional materials, manuals, and guidelines provided by SHOCKWAVE PRO USA LLC, Pulse Wave, Asclepius Medical Holdings LLC are assumed to have been read and understood by the Purchaser upon receipt. The Purchaser agrees to strictly adhere to all instructions contained in any material provided by the Manufacturer prior to the delivery and operation of the Device. Failure to follow these instructions may result in injury, damage, or other adverse consequences, for which the Manufacturer disclaims all responsibility, and the purchaser agrees to release SHOCKWAVE PRO USA LLC, Pulse Wave, Asclepius Medical Holdings LLC pertaining to any use or operation outside the explicit use detailed in any instructions or manuals provided.

6. Acknowledgment

By purchasing and using the Device, the Purchaser acknowledges that they have read and understood this Disclaimer, and agree to abide by all terms and conditions contained herein.

7. CLAIMS MADE

This manufacture does not claim that this machine can cure any disease or musculoskeletal condition. This manufacture has made no claim that this device has been evaluated by the FDA or approved in any way by the FDA, or our facility. Any claims made by the manufacturer are clinical observations by licensed medical professionals utilizing the device. Their claims have not been approved or evaluated by the FDA. Current FDA Policies state that Class I Medical Devices DO NOT require individual FDA Device registration so long as the manufacturer is a Registered FDA Medical Device Manufacturer. The phrase or terminology "Manufactured In The USA" makes reference to the use and procurement of parts and pieces sourced both domestically and globally and assembled in the United States of America. All final assembly, testing, service, warranty, repair are performed at our facility here in the United States. Claims made regarding CE Credit may not be applicable for all US States. Please check with the support team to ensure our CE credits are allowable in your state. The Pulse Wave device is classified as a low-intensity extracorporeal shockwave therapy. This value is within the range of low-intensity extracorporeal shock wave therapy (ESWT), which is generally defined as having an energy flux density below 0.1 mJ/mm².

8. 8. CLAIMS MADE

9. The Pulse Wave Device nor its manufacture have been individually cleared or approved in anyway by the FDA or any other regulatory bodies for the specific treatment of any musculoskeletal condition. Any mention of specific musculoskeletal conditions in any marketing or literature provided by Pulse Wave or its manufacture are purely antidotal and off label use of the technology and in no way imply clearance or approval.