Identity
- Trade Name
- Comfytopia FDA UDI
- Generic Name
- Multiple-joint lower limb orthosis FDA UDI
- Device Name
- BRACOO FP30 Ankle Fulcrum wrap Black S/M FDA UDI
- Model / Reference
- FP30 FDA UDI
- Description
- BRACOO FP30 Ankle Fulcrum wrap Black S/M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00819567011608 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Category: Multiple-joint lower limb orthosis
Comfytopia by Comfytopia, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Lower Limb Orthotics — Boston Brace International, Inc. · Class I
- Dynamic Femur Fracture Brace — ORTHOPEDIATRICS CORP. · Class I
- Lower Limb Orthotics — Boston Brace International, 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
- Comfytopia, Inc.
Sources (1)
- FDA UDI 4a9d5eb7-d37e-4874-beba-725f3c470733 33 fields · synced May 30, 2026