Identity
- Trade Name
- TM "Rehabilitimed" GS-2 M Comfort FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- The graphite-colored ankle-foot orthosis provides external semi-rigid fixation. The detachable orthosis is reinforced on the sides with four metal stiffening ribs, curved according to anatomical shapes and covered with a special material for a comfortable fit to the bone protrusions of the joint. Convenient fastening on the leg is carried out due to textile fasteners. Made of multilayer material with a cotton layer to the body and polyamide on the outside. FDA UDI
- Model / Reference
- GS-2 M Comfort FDA UDI
- Description
- The graphite-colored ankle-foot orthosis provides external semi-rigid fixation. The detachable orthosis is reinforced on the sides with four metal stiffening ribs, curved according to anatomical shapes and covered with a special material for a comfortable fit to the bone protrusions of the joint. Convenient fastening on the leg is carried out due to textile fasteners. Made of multilayer material with a cotton layer to the body and polyamide on the outside. FDA UDI
Identifiers
- Catalog Number
- GS-2 M Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097722626 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" GS-2 M Comfort by Reabilitimed Tov — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ankle/foot orthosis.
- Strp Only, Long, SA Wide Fl 12.5 E Stop — Becker Orthopedic Appliance Company · Class I
- Strp, SFL, 8.25in C Stop , AJT, SA, B — Becker Orthopedic Appliance Company · Class I
- Strp, Spl, WF Cal Pl, AJT, SA B, Free Mot LM/RL — Becker Orthopedic Appliance Company · Class I
- ALIMED ANKLE BRACE ALL AIR TUBE — AliMed, LLC · Class I
- Ankle support with 2 straps - Neoprene - onesize — ΜΙΧΑΛΗΣ ΚΟΥΓΙΟΥΜΤΖΗΣ ΚΑΙ ΣΙΑ Ε.Ε. · Class I
- Rebound® Air Walker LT — Össur Iceland ehf. · Class I
- Strp Blank Insert Only, SA, A/B Size, 3in Free Mot — Becker Orthopedic Appliance Company · Class I
- STABIBOOT 3D — GROUPE SOBER SAS · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Reabilitimed Tov
Sources (1)
- FDA UDI 4f8d18ab-1a5d-48a3-a64f-c36c09ae3130 36 fields · synced Jun 6, 2026