Identity
- Trade Name
- TM "Rehabilitimed" OT-1V-U S Comfort FDA UDI
- Generic Name
- Thoracic spine orthosis FDA UDI
- Device Name
- Semi-rigid beige posture corrector, used for strong fixation of the spine. Stabilizes the spine due to 4 metal stiffening ribs and strengthens the abdominal muscle wall using the compression effect of the elastic bandage fabric. Made of durable elastic bandage fabric made of polyamide and elastane and multilayer material with a cotton layer to the body and polyamide on the outside. FDA UDI
- Model / Reference
- OT-1V-U S Comfort FDA UDI
- Description
- Semi-rigid beige posture corrector, used for strong fixation of the spine. Stabilizes the spine due to 4 metal stiffening ribs and strengthens the abdominal muscle wall using the compression effect of the elastic bandage fabric. Made of durable elastic bandage fabric made of polyamide and elastane and multilayer material with a cotton layer to the body and polyamide on the outside. FDA UDI
Identifiers
- Catalog Number
- OT-1V-U S Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097722336 FDA UDI
- FDA Product Code
- IPT FDA UDI
- GMDN Term
- Thoracic spine orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 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: Thoracic spine orthosis
TM "Rehabilitimed" OT-1V-U S Comfort by Reabilitimed Tov — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 b88720fa-474b-4005-b866-94b737446905 36 fields · synced May 30, 2026