Identity
- Trade Name
- UltraStim X Derma FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Model / Reference
- USXD2020 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851913006388 FDA UDI
- 510(k) Number
- K130987 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- Not 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
The UltraStim X Derma device is a noninvasive, single-use transcutaneous electrical stimulation (TENS) electrode designed for therapeutic use on the skin. It features a flat, flexible conductive pad with an adhesive or preformed shape, connected to a conductive wire. This reusable device provides effective pain relief and has been approved by the FDA for use in various medical conditions.
Cleared under the same submission
K130987 also covers:
- EconoStim — AXELGAARD MANUFACTURING CO., LTD.
- EconoStim — AXELGAARD MANUFACTURING CO., LTD.
- ValuTrode Lite Foam — AXELGAARD MANUFACTURING CO., LTD.
- ProStim Electrodes — AliMed, LLC
- ProStim Electrodes — AliMed, LLC
- Slendertone Replacement Abdominal Toning Gel Pads — Bio-Medical Research, Ltd.
- The Flex Belt Replacement Electrodes — Bio-Medical Research, Ltd.
- Calmare Therapeutics, Inc. — CALMARE THERAPEUTICS INCORPORATED
- CHATTANOOGA — DJO, LLC
- CHATTANOOGA — DJO, LLC
- COMPEX — DJO, LLC
- COMPEX — DJO, LLC
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
- Axelgaard Manufacturing Co., Ltd.
Sources (1)
- FDA UDI ae41880f-8318-4779-86db-9504a2d3d707 36 fields · synced Jul 30, 2026