Identity
- Trade Name
- Revitive Medic Plus FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- Neuromuscular Electrical Stimulation and Transcutaneous Electrical Nerve Stimulation Device FDA UDI
- Model / Reference
- 3156AD FDA UDI
- Description
- Neuromuscular Electrical Stimulation and Transcutaneous Electrical Nerve Stimulation Device FDA UDI
Identifiers
- Catalog Number
- 3158 FDA UDI
- Primary DI / UDI-DI
- 00858058005146 FDA UDI
- 510(k) Number
- K190924 FDA UDI
- FDA Product Code
- NYN FDA UDIIPF FDA UDIGZJ FDA UDINUH FDA UDINGX FDA UDI
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI890.5850 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Analgesic transcutaneous electrical nerve stimulation systemPhysical therapy transcutaneous electrical stimulation system, line-powered
Revitive Medic Plus by Actegy , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K190924 also covers:
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
- Actegy , Ltd.
Sources (1)
- FDA UDI e09df9e4-1eee-4758-b647-7009c2c3f1d0 37 fields · synced May 30, 2026