Identity
- Trade Name
- Pro Comfort Lumbar Support FDA UDI
- Generic Name
- Lumbar spine orthosis FDA UDI
- Device Name
- Pro Comfort Lumbar Support FDA UDI
- Model / Reference
- 4470 FDA UDI
- Description
- Pro Comfort Lumbar Support FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850027494470 FDA UDI
- FDA Product Code
- ITW FDA UDI
- GMDN Term
- Lumbar spine 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Lumbar spine orthosis
Pro Comfort Lumbar Support by Home Aide Diagnostics, Inc. — 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
- TM "Rehabilitimed" I-6M XS Comfort — REABILITIMED TOV · 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
- Home Aide Diagnostics, Inc.
Sources (1)
- FDA UDI c97b8279-2648-4452-be95-17cc9f5d0f87 34 fields · synced May 30, 2026