Identity
- Trade Name
- Wavelength FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- Wavelength Ultrasound Lotion 8.45oz FDA UDI
- Model / Reference
- NTPD201X FDA UDI
- Description
- Wavelength Ultrasound Lotion 8.45oz FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628108100066 FDA UDI
- 510(k) Number
- K013212 FDA UDI
- FDA Product Code
- MUI FDA UDI
- GMDN Term
- Skin topical coupling gel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin topical coupling gel
Wavelength by National Therapy Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin topical coupling gel.
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Ecogel 200 — Eco-Med Pharmaceutical Inc · Class II
- Clear Image Singles — NEXT Medical Products Company · Class II
- Pharmaceutical Innovations — Pharmaceutical Innovations, Inc. · Class II
- DynaGel™ Ultrasound Gel, 5 Liters, Clear — Dynatronics Corp. · Class II
- RED Medical Supplies — Red Medical Supplies Ltd · Class II
- LG — COMPASS HEALTH BRANDS CORP. · Class II
- Novaplus — NEXT Medical Products Company · Class II
Cleared under the same submission
K013212 also covers:
- CLINICAL HEALTH SERVICES, INC. — CLINICAL HEALTH SERVICES, INC.
- Dynatron® Lotion, 1 Gallon — Dynatronics Corp.
- Sonigel Lotion with Aloe Vera — METTLER ELECTRONICS CORP.
- Sonigel Lotion with Aloe Vera — METTLER ELECTRONICS CORP.
- Wavelength — National Therapy Products, Inc.
- Wavelength — National Therapy Products, Inc.
- Wavelength — National Therapy Products, Inc.
- Scrip Hessco — Scriphessco
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- National Therapy Products, Inc.
Sources (1)
- FDA UDI ec159844-f11a-4360-b072-f1cc8b7f593b 35 fields · synced Jun 1, 2026