Identity
- Trade Name
- TM "Rehabilitimed" BR-1 M Comfort FDA UDI
- Generic Name
- Lumbar spine orthosis FDA UDI
- Device Name
- It is a graphite colored chest bandage. The part of the bandage that fits to the back is made of elastic fabric, and the front-side parts are made of rich ball material (a special velor tri-laminated fabric (glued in a special way with polyurethane foam) with a rich terry cloth, complete with 2 plastic ribs. FDA UDI
- Model / Reference
- BR-1 M Comfort FDA UDI
- Description
- It is a graphite colored chest bandage. The part of the bandage that fits to the back is made of elastic fabric, and the front-side parts are made of rich ball material (a special velor tri-laminated fabric (glued in a special way with polyurethane foam) with a rich terry cloth, complete with 2 plastic ribs. FDA UDI
Identifiers
- Catalog Number
- BR-1 M Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097723685 FDA UDI
- FDA Product Code
- IPX FDA UDI
- GMDN Term
- Lumbar 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: Lumbar spine orthosis
TM "Rehabilitimed" BR-1 M Comfort by Reabilitimed Tov — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lumbar spine orthosis.
- WELLBRACE — PANTYMED S.A. · Class I
- Archimed 631 Spinal Brace — MEDICAL SPECIALTIES INCORPORATED · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Back-n-Shape II — MEDICAL SPECIALTIES INCORPORATED · Class I
- CoreTech — VIVE HEALTH LLC · Class I
- Pro Comfort Lumbar Support — HOME AIDE DIAGNOSTICS, 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 10f9babe-3a4a-46f7-ad60-caf20b650d89 36 fields · synced May 30, 2026