Identity
- Trade Name
- Sonigel Lotion with Aloe Vera FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Sonigel 1863 (1 x 1 gallon) FDA UDI
- Model / Reference
- 1863 FDA UDI
- Description
- Sonigel 1863 (1 x 1 gallon) FDA UDI
Identifiers
- Catalog Number
- 1863 FDA UDI
- Primary DI / UDI-DI
- 00816864020326 FDA UDI
- 510(k) Number
- K013212 FDA UDI
- FDA Product Code
- MUI FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use 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
Yes
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
Yes
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-use
Sonigel Lotion with Aloe Vera by Mettler Electronics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Transcutaneous electrical stimulation electrode, single-use.
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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.
- Wavelength — National Therapy Products, Inc.
- 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 |
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Manufacturer
- Manufacturer
- Mettler Electronics Corp.
Sources (1)
- FDA UDI f9a35969-b945-4855-97f9-32b7935bdc52 36 fields · synced Jun 8, 2026