Identity
- Trade Name
- TM "Rehabilitimed" K-1TM XL Comfort FDA UDI
- Generic Name
- Knee support orthosis FDA UDI
- Device Name
- The orthopedic device is graphite in color, has a dense structure, is an elastic circular knee joint orthosis made of aeroprene (aeroprene is a soft, breathable, highly elastic neoprene that has additional perforation holes on the entire surface that improve air and moisture exchange) with an insert made of a special mesh fabric under the knee, equipped with a relief limiting silicone ring around the hole for the patella, reinforced with two flexible spring stiffening ribs on the side surfaces and additional fixing straps. FDA UDI
- Model / Reference
- K-1TM XL Comfort FDA UDI
- Description
- The orthopedic device is graphite in color, has a dense structure, is an elastic circular knee joint orthosis made of aeroprene (aeroprene is a soft, breathable, highly elastic neoprene that has additional perforation holes on the entire surface that improve air and moisture exchange) with an insert made of a special mesh fabric under the knee, equipped with a relief limiting silicone ring around the hole for the patella, reinforced with two flexible spring stiffening ribs on the side surfaces and additional fixing straps. FDA UDI
Identifiers
- Catalog Number
- K-1TM XL Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097721506 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-1TM XL 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 f7a47776-18ae-4856-8d06-39dfab98af89 36 fields · synced May 30, 2026