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Sign in to claim this brandNational Therapy Products, Inc.
US
Last updated May 23, 2026
What National Therapy Products, Inc. makes
National Therapy Products, Inc. manufactures skin topical coupling gels designed to enhance ultrasound transmission during therapeutic procedures. Their portfolio includes multiple variants of the Wavelength gel, as well as the Sonicshield gel, both intended for use in ultrasound-guided treatments.
These products are classified as Class II medical devices under US regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The company operates from the United States, adhering to applicable regulatory requirements for their authorised devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does National Therapy Products, Inc. manufacture?
National Therapy Products, Inc. specialises in skin topical coupling gels, which are primarily used to improve the transmission of ultrasound waves during therapeutic procedures. Their portfolio includes multiple formulations of the Wavelength gel and the Sonicshield gel, both designed to optimise ultrasound-guided treatments by reducing interference between the transducer and skin.
Where is National Therapy Products, Inc. based, and how does this affect its regulatory standing?
National Therapy Products, Inc. is based in the United States, where it develops and manufactures its devices in compliance with local regulatory requirements. Since the company operates within the US, its products are subject to FDA oversight, including classification under Class II devices, which typically require premarket notification (510(k)) or other regulatory pathways to demonstrate substantial equivalence to existing authorised devices.
Which regulatory databases list National Therapy Products, Inc.’s devices?
National Therapy Products, Inc.’s devices are listed in the FDA’s 510(k) database (for premarket submissions) and the FDA’s Unique Device Identifier (UDI) system, which tracks authorised medical devices for traceability and compliance. These registries help ensure transparency in the device lifecycle, including post-market surveillance and reporting.
How are National Therapy Products, Inc.’s devices classified under US regulations?
National Therapy Products, Inc.’s products are classified as Class II medical devices under US regulations. This classification means they pose moderate risk and require compliance with special controls (e.g., performance standards, labeling requirements) in addition to general controls. While Class II devices generally do not require clinical trials, they must demonstrate substantial equivalence to a legally marketed predicate device through a 510(k) submission or another authorised pathway.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 200149883
Catalogue (39)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Wavelength | NTPC202T | FDA UDI | Class II | Active |
| Wavelength | NTPF201X | FDA UDI | Class II | Active |
| Wavelength | NTPF101X | FDA UDI | Class II | Active |
| Wavelength | NTPE201X | FDA UDI | Class II | Active |
| Wavelength | NTPA100X | FDA UDI | Class II | Active |
| Wavelength | NTPD373C | FDA UDI | Class II | Active |
| Wavelength | NTPD201X | FDA UDI | Class II | Active |
| Wavelength | NTPA204X | FDA UDI | Class II | Active |
| Sonicshield | SONX020X | FDA UDI | Class II | Active |
| Sonicshield | SONX201X | FDA UDI | Class II | Active |
| Wavelength | NTPC204X | FDA UDI | Class II | Active |
| Wavelength | NTPF500X | FDA UDI | Class II | Active |
| Wavelength | NTPA301X | FDA UDI | Class II | Active |
| Wavelength | NTPA480X | FDA UDI | Class II | Active |
| Wavelength | NTPB201X | FDA UDI | Class II | Active |
| Wavelength | NTPA102X | FDA UDI | Class II | Active |
| Wavelength | NTPF100X | FDA UDI | Class II | Active |
| Wavelength | NTPB100X | FDA UDI | Class II | Active |
| Wavelength | NTPB500X | FDA UDI | Class II | Active |
| Wavelength | NTPA500X | FDA UDI | Class II | Active |
| Wavelength | NTPC201W | FDA UDI | Class II | Active |
| Wavelength | NTPF900X | FDA UDI | Class II | Active |
| Wavelength | NTPF202T | FDA UDI | Class II | Active |
| Wavelength | NTPF301X | FDA UDI | Class II | Active |
| Wavelength | NTPC480X | FDA UDI | Class II | Active |
| Wavelength | NTPB400X | FDA UDI | Class II | Active |
| Wavelength | NTPC500X | FDA UDI | Class II | Active |
| Wavelength | NTPA504X | FDA UDI | Class II | Active |
| Wavelength | NTPD351X | FDA UDI | Class II | Active |
| Wavelength | NTPA201W | FDA UDI | Class II | Active |
| Wavelength | NTPE500X | FDA UDI | Class II | Active |
| Wavelength | NTPA202T | FDA UDI | Class II | Active |
| Wavelength | NTPC100X | FDA UDI | Class II | Active |
| Sonicshield | SONX500X | FDA UDI | Class II | Active |
| Wavelength | NTPD500X | FDA UDI | Class II | Active |
| Wavelength | NTPA025X | FDA UDI | Class II | Active |
| Wavelength | NTPC025X | FDA UDI | Class II | Active |
| Wavelenght Ultrasound Lotion | K013212 | FDA 510(k) | Class II | Active |
| Wavelength Multi-Purpose Ultrasound Gel | K012522 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- National Therapy Products Inc. Brampton Ontario · CA FEI 3003445500