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Legal Disclaimer | Pulse Wave Focused Shockwave Therapy

Legal Disclaimer

Pulse Wave™ Focused Shockwave Therapy — Important Legal Information

Last Updated: March 2026

1. Medical Disclaimer

Neither Pulse Wave™, its affiliates, parent company, or subsidiaries dispense medical advice. The contents of this website do not constitute medical, legal, or any other type of professional advice. Information related to various health, medical, and sports conditions and their treatment is not a substitute for the advice provided by a physician or other medical professional. You should not use the information contained herein for diagnosing a health or medical problem or disease.

2. FDA & Regulatory Status

Pulse Wave™ is not marketed, advertised, or claimed to treat or cure any medical conditions, and is not marketed, advertised, or claimed to hold any FDA approvals or other FDA clearances other than FDA registration.

Device Contraindications & Use Restrictions:

  • This device is not cleared for, intended use for, or advertised to treat the heart, brain, skin, liver, or kidney.
  • All major organs are a direct contraindication for the Pulse Wave™ Device.
  • This device is not cleared for, intended use for, or advertised to reduce or eliminate a mass such as a calcified plaque, stone, or other.
  • We make no claims to methods, processes, or strategies for utilization of Shockwave Technology to be used on human tissues, organs, or cells.
  • We make no claim as to the effect of shockwave therapy on stem cells.
  • We make no claims as to the use of this device for the treatment of Erectile Dysfunction.

3. Full Legal Disclaimer

See legal disclaimer for full claims made information and additional resources. Read all terms, conditions, and legal disclaimers prior to making any purchases.

This manufacturer does not claim that this machine can cure any disease or musculoskeletal condition. The manufacturer is an FDA Registered Medical Device Manufacturer holding current and up to date Registration Status. This is not to imply that this device has been individually evaluated by the FDA or approved in any way by the FDA. Any claims referenced by the manufacturer referencing specific or general musculoskeletal conditions have not been approved or evaluated by the FDA.

Any and all information pertained in any reference text, manual, or information provided is solely for reference purposes and does not in itself constitute medical advice, but rather reference material and educational references for licensed medical providers to be used to determine appropriate courses of care and professional resources to be used in their own professional practices.

All medical providers should adhere to all appropriate rules, regulations, and standards of practice for their specific licensure, state and local requirements, and specific boards and appropriate professional standards. It is the responsibility of the individual medical providers to ensure they maintain proper continuing education regarding the use of this technology and appropriate malpractice, liability, professional liability, and any other appropriate insurance specific for their individual fields of practice.

4. Device & Treatment Disclaimers

This device is not cleared for, intended use for, or advertised to treat the heart, brain, skin, liver, kidney, or any other organ tissue. This device is not cleared for, intended use for erectile dysfunction. All major organs are a direct contraindication for the Pulse Wave™ Device. This device is not cleared for, intended use for, or advertised to reduce or eliminate a mass such as a calcified plaque, stone, or other. Use of this device is directly contraindicated for such masses or uses.

We make no claim to the activation, recruitment, or any other effect on stem cells. Pulse Wave™, its affiliates, or parent companies make no claims on methods, protocols, or processes related to the use of shockwave therapy on human tissues. We make no claims on methods, protocols, or processes related to the treatment of Erectile Dysfunction. This device is not cleared for the treatment of Erectile Dysfunction.

5. Manufacturing & Terminology Disclosures

The phrase or terminology "Manufactured In The USA" and "Assembled 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.

Pulse Wave™, its affiliates, parent company, or subsidiaries hold a vendor partnership with NCMIC. NCMIC is a copyright and trademark owned by NCMIC. 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 phrase or terminology "no consumables" makes reference to the technology not using or consuming any traditional medical consumables. Applicator lifespan has shown an average of 1 million pulses and average life of over 1 year of service. "A medical consumable is any medical supply or item that is intended for one-time use or is used up during a medical procedure or over a short period of time. These items are not reusable and need to be replenished regularly." This unit does not use consumables by this definition.

Some measurements and technical specifications are extrapolated from preexisting comparative and established values when direct numerical values are not directly available.

6. Intellectual Property & Proprietary Information

Any use of provided information, schematics, technical specifications, manuals, educational materials by outside parties is strictly prohibited and will be prosecuted to the full extent of the law.

7. Social Media Disclaimer

This site is not part of the Facebook website or Facebook Inc.

8. CGI Disclaimer

Some images in part or whole have been generated utilizing Computer Graphic Imagery to display either detail or 3D structure. Some internal components may be enlarged to show detail. All images contained in this website are protected under copyright and trademark law and should not be used or duplicated in any way by any outside party.

The images shown on this website or in marketing material due to CGI alteration may not look exactly like the machine, unit, or components themselves. Proportions, ratios, and color may be altered to show 3D animation, detail, and altered to fit certain aspect and photo requirements.