Identity
- Trade Name
- TM "Rehabilitimed" K-1P S Comfort FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Device Name
- The orthopedic device is graphite in color, the structure is dense, right, it is an elastic circular knee joint orthosis made of aeroprene (aeroprene is a soft, breathable highly elastic neoprene that has additional perforations over the entire surface, which enhances air and moisture exchange.). Two pairs of lateral spring stiffening ribs allow for moderate support of lateral displacement of the knee joint. The sealed silicone ring ensures fixation of the knee joint and the correct position of the patella, the reinforcing insert with tightening above and below the ring creates additional stabilization on the lateral and medial sides of the joint. FDA UDI
- Model / Reference
- K-1P S Comfort FDA UDI
- Description
- The orthopedic device is graphite in color, the structure is dense, right, it is an elastic circular knee joint orthosis made of aeroprene (aeroprene is a soft, breathable highly elastic neoprene that has additional perforations over the entire surface, which enhances air and moisture exchange.). Two pairs of lateral spring stiffening ribs allow for moderate support of lateral displacement of the knee joint. The sealed silicone ring ensures fixation of the knee joint and the correct position of the patella, the reinforcing insert with tightening above and below the ring creates additional stabilization on the lateral and medial sides of the joint. FDA UDI
Identifiers
- Catalog Number
- K-1P S Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097721599 FDA UDI
- FDA Product Code
- ITM FDA UDI
- GMDN Term
- Knee support 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: Knee support orthosis
TM "Rehabilitimed" K-1P S Comfort by Reabilitimed Tov — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee support orthosis.
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- MEDI — MEDI MANUFACTURING, INC. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- NON FRANCHISE — DJO, LLC · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Gripper Hinged Knee — MEDICAL SPECIALTIES INCORPORATED · Class I
- DeRoyal — DEROYAL INDUSTRIES, 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 |
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Manufacturer
- Manufacturer
- Reabilitimed Tov
Sources (1)
- FDA UDI 94ef5de0-ad9f-46dd-bf72-83f97304f81e 36 fields · synced May 30, 2026