Identity
- Trade Name
- TM "Rehabilitimed" K-1 S Comfort FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Device Name
- The orthopedic device is graphite in color, it is an orthosis for the knee joint made of multilayer material with an inner layer of 100% cotton fabric, equipped with monocentric hinges located on the side surfaces and two parallel straps with textile fasteners in the lower third of the thigh and upper third of the shin. The orthosis provides external semi-rigid fixation of the knee joint, unloading its capsular ligamentous apparatus and stabilizing the patella. FDA UDI
- Model / Reference
- K-1 S Comfort FDA UDI
- Description
- The orthopedic device is graphite in color, it is an orthosis for the knee joint made of multilayer material with an inner layer of 100% cotton fabric, equipped with monocentric hinges located on the side surfaces and two parallel straps with textile fasteners in the lower third of the thigh and upper third of the shin. The orthosis provides external semi-rigid fixation of the knee joint, unloading its capsular ligamentous apparatus and stabilizing the patella. FDA UDI
Identifiers
- Catalog Number
- K-1 S Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097717929 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 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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- 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 67d426cd-6351-4991-8672-66e51e699787 36 fields · synced May 30, 2026