Identity
- Trade Name
- ComfyHealth FDA UDI
- Generic Name
- Multiple-joint lower limb orthosis FDA UDI
- Device Name
- BRACOO LE70 Calf Fulcrum Sleeve Comfort Fit Black L/XL-size Pair FDA UDI
- Model / Reference
- LE70 FDA UDI
- Description
- BRACOO LE70 Calf Fulcrum Sleeve Comfort Fit Black L/XL-size Pair FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719879643336 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- Multiple-joint lower limb orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
ComfyHealth by Comfy Health Group Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Comfy Health Group Co., Ltd.
Sources (1)
- FDA UDI 7eeb38fc-fa4c-4d4a-ac55-034901a9eb09 34 fields · synced May 30, 2026