Identity
- Trade Name
- H-Wave EWL FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Electrode, Cutaneous FDA UDI
- Model / Reference
- 30007 FDA UDI
- Description
- Electrode, Cutaneous FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00869844000214 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
- 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
No
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-use
H-Wave EWL by Electronic Waveform Lab, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130987 also covers:
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- ProStim Electrodes — AliMed, LLC
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- 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
- Electronic Waveform Lab, Inc.
Sources (1)
- FDA UDI ad701866-792b-4cab-b731-f2b7aeef6e28 35 fields · synced Jun 1, 2026