Identity
- Trade Name
- Kneehab XP FDA UDI
- Generic Name
- Arthritis TENS system FDA UDI
- Model / Reference
- 412 FDA UDI
Identifiers
- Catalog Number
- 0412-5001 FDA UDI
- Primary DI / UDI-DI
- 15099058412004 FDA UDI
- FDA Product Code
- NYN FDA UDIIPF FDA UDIGZJ FDA UDI
- GMDN Term
- Arthritis TENS 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation systemArthritis TENS system
Kneehab XP by Bio-Medical Research, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthritis TENS system.
- PlayMakar — Playmakar, Inc. · Class II
- PlayMakar — Playmakar, Inc. · Class II
- AURAWAVE — Endurance Therapeutics · Class II
- iReliev — EXCELHEALTH, INC. · Class II
- iReliev — EXCELHEALTH, INC. · Class II
- iReliev — EXCELHEALTH, INC. · Class II
- iReliev — EXCELHEALTH, INC. · Class II
- PlayMakar — Playmakar, Inc. · 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
- Bio-Medical Research, Ltd.
Sources (1)
- FDA UDI d5e904da-edac-4cf2-a1bf-838e79e43817 33 fields · synced May 30, 2026