Identity
- Trade Name
- TM "Rehabilitimed" DS-1 UNI Comfort FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- It has the appearance of an open structure in the form of a boot, to which a transverse crossbar is attached, which prevents rotation of the foot and the entire leg to the right, left, and additional fixing straps keep the foot from bending movements up and down. Graphite color. FDA UDI
- Model / Reference
- DS-1 UNI Comfort FDA UDI
- Description
- It has the appearance of an open structure in the form of a boot, to which a transverse crossbar is attached, which prevents rotation of the foot and the entire leg to the right, left, and additional fixing straps keep the foot from bending movements up and down. Graphite color. FDA UDI
Identifiers
- Catalog Number
- DS-1 UNI Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097716854 FDA UDI
- FDA Product Code
- ITW FDA UDI
- GMDN Term
- Ankle/foot 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: Ankle/foot orthosis
TM "Rehabilitimed" DS-1 UNI Comfort by Reabilitimed Tov — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 be9bfa6b-ce51-4aaf-ab10-177419e61d76 35 fields · synced May 31, 2026