Identity
- Trade Name
- TM "Rehabilitimed" RP-6 XS Comfort FDA UDI
- Generic Name
- Elbow orthosis FDA UDI
- Device Name
- It is a graphite-colored hand wrap. Made of durable material with a high cotton content and equipped with an adjustable strap for the neck and upper arm. The height and tightness of the fit to the body are adjustable using the textile fastener tapes on the product's straps. FDA UDI
- Model / Reference
- RP-6 XS Comfort FDA UDI
- Description
- It is a graphite-colored hand wrap. Made of durable material with a high cotton content and equipped with an adjustable strap for the neck and upper arm. The height and tightness of the fit to the body are adjustable using the textile fastener tapes on the product's straps. FDA UDI
Identifiers
- Catalog Number
- RP-6 XS Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097719176 FDA UDI
- FDA Product Code
- IOY FDA UDI
- GMDN Term
- Elbow orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Elbow orthosis
TM "Rehabilitimed" RP-6 XS Comfort by Reabilitimed Tov — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Elbow orthosis.
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DONJOY PERFORMANCE — DJO, LLC · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- BMI — Blake Manufacturing, Inc. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- NEOPRENE TENNIS ELBOW LONG — BIRD & CRONIN, LLC · Class I
- BMI — Blake Manufacturing, Inc. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Reabilitimed Tov
Sources (1)
- FDA UDI 8a2bac32-030d-44cc-ac71-374601a528ee 36 fields · synced May 30, 2026