Identity
- Trade Name
- WELL-LIFE FDA UDI
- Generic Name
- Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI
- Device Name
- The Well Life Self Adhesive Electrode / CM, FA, PU and SP series are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Well Life Self Adhesive Electrode / CM, FA, PU and SP series are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS, EMS, IF, and PGS. FDA UDI
- Model / Reference
- CM-5050 FDA UDI
- Description
- The Well Life Self Adhesive Electrode / CM, FA, PU and SP series are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Well Life Self Adhesive Electrode / CM, FA, PU and SP series are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS, EMS, IF, and PGS. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719872260028 FDA UDI
- FDA Product Code
- LIH FDA UDI
- GMDN Term
- Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Physical therapy transcutaneous electrical stimulation system, line-powered
Well-Life by Well-Life Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Physical therapy transcutaneous electrical stimulation system, line-powered.
- RT300 — Restorative Therapies, Inc. · Class II
- Revitive Medic — Actegy , Ltd. · Class II
- RT300 — Restorative Therapies, Inc. · Class II
- NeoControl — MAGIC RACE LLC · Class II
- RT300 — Restorative Therapies, Inc. · Class II
- NeoTone — MAGIC RACE LLC · Class II
- Johari Digital Healthcare Limited — SYRMA JOHARI MEDTECH LIMITED · Class II
- Mettler Electronics Corp. — SYRMA JOHARI MEDTECH LIMITED · Class II
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
- Well-Life Healthcare, Inc.
Sources (1)
- FDA UDI fb1e5c6d-966e-4988-aba2-1d9b83a01f77 33 fields · synced May 30, 2026