Identity
- Trade Name
- TM "Rehabilitimed" K-1 L Comfort FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Device Name
- Detachable knee joint orthosis in graphite color, provides external semi-rigid fixation of the knee joint, relieves its capsular ligament apparatus and stabilizes the kneecap. Equipped with 2 monocentric orthopedic hinges and a system of reinforcing straps. Made of multilayer material with a cotton layer to the body and polyamide on the outside. FDA UDI
- Model / Reference
- K-1 L Comfort FDA UDI
- Description
- Detachable knee joint orthosis in graphite color, provides external semi-rigid fixation of the knee joint, relieves its capsular ligament apparatus and stabilizes the kneecap. Equipped with 2 monocentric orthopedic hinges and a system of reinforcing straps. Made of multilayer material with a cotton layer to the body and polyamide on the outside. FDA UDI
Identifiers
- Catalog Number
- K-1 L Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097722961 FDA UDI
- FDA Product Code
- ITQ 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-1 L 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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- MECRON Knee Flexion 10deg L:500mm, OS:590mm, US:380mm — Darco (Europe) GmbH · Class I
- 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 6fcaa6ab-cf9f-4f09-8113-e85b97faa853 36 fields · synced May 30, 2026