Identity
- Trade Name
- Clever Choice FDA UDI
- Generic Name
- Lumbosacral spine orthosis, hernia/ptosis support FDA UDI
- Device Name
- Orthopedic Back Brace FDA UDI
- Model / Reference
- Orthopedic Back Brace FDA UDI
- Description
- Orthopedic Back Brace FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00898302001890 FDA UDI
- FDA Product Code
- MRI FDA UDI
- GMDN Term
- Lumbosacral spine orthosis, hernia/ptosis support 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
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
No
FDA UDI
Category: Lumbosacral spine orthosis, hernia/ptosis support
Clever Choice by Simple Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lumbosacral spine orthosis, hernia/ptosis support.
- Ultra Support Orthopedic Back Brace — HOME AIDE DIAGNOSTICS, INC. · Class I
- VIVE — VIVE HEALTH LLC · Class I
- Pro Comfort Universal Lumbar Support Back Brace — 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
- Simple Diagnostics
Sources (1)
- FDA UDI e67daecd-899d-42e9-8168-9786057a1d32 34 fields · synced May 30, 2026