Identity
- Trade Name
- ComfyHealth FDA UDI
- Generic Name
- Static magnetic orthopaedic orthosis FDA UDI
- Device Name
- BRACOO MS61 Maternity Belt Fulcrum Wrap Easy Fit & Soft Pink FDA UDI
- Model / Reference
- MS61 FDA UDI
- Description
- BRACOO MS61 Maternity Belt Fulcrum Wrap Easy Fit & Soft Pink FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719879644043 FDA UDI
- FDA Product Code
- ISR FDA UDI
- GMDN Term
- Static magnetic orthopaedic orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3025 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: Static magnetic orthopaedic orthosis
ComfyHealth by Comfy Health Group Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Static magnetic orthopaedic orthosis.
- Comfytopia — Comfytopia, Inc. · Class I
- Comfytopia — Comfytopia, Inc. · Class I
- ComfyHealth — Comfy Health Group Co., Ltd. · Class I
- ComfyHealth — Comfy Health Group Co., Ltd. · Class I
- ComfyHealth — Comfy Health Group Co., Ltd. · Class I
- ComfyHealth — Comfy Health Group Co., Ltd. · Class I
- ComfyHealth — Comfy Health Group Co., Ltd. · Class I
- ComfyHealth — Comfy Health Group Co., Ltd. · 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
- Comfy Health Group Co., Ltd.
Sources (1)
- FDA UDI d7a7af9f-1323-435d-853c-12face56eaca 33 fields · synced May 30, 2026