Identity
- Trade Name
- TM "Rehabilitimed" RP-6K-M1 UNIp-1 Comfort FDA UDI
- Generic Name
- Elbow orthosis FDA UDI
- Device Name
- It is an orthosis for the shoulder and elbow joint, graphite color. Made of multilayer material (special velor tripled fabric (glued in a special way with polyurethane foam) with cotton terry cloth) and designed so that the two sleeves supporting the arm are easily adjusted in height using a textile fastener. Additionally equipped with a belt around the chest to press the arm to the body for its reliable fixation. FDA UDI
- Model / Reference
- RP-6K-M1 UNIp-1 Comfort FDA UDI
- Description
- It is an orthosis for the shoulder and elbow joint, graphite color. Made of multilayer material (special velor tripled fabric (glued in a special way with polyurethane foam) with cotton terry cloth) and designed so that the two sleeves supporting the arm are easily adjusted in height using a textile fastener. Additionally equipped with a belt around the chest to press the arm to the body for its reliable fixation. FDA UDI
Identifiers
- Catalog Number
- RP-6K-M1 UNIp-1 Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097719473 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-6K-M1 UNIp-1 Comfort by Reabilitimed Tov — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Reabilitimed Tov
Sources (1)
- FDA UDI 69bece4c-670f-4d8c-81d9-6f25307c3591 36 fields · synced May 29, 2026