Identity
- Trade Name
- cofoe FDA UDI
- Generic Name
- Lumbar spine orthosis FDA UDI
- Device Name
- It is intended for use in correcting improper posture, such as hunching or slouching, and improving overall body alignment. It is suitable for both adults and children who need assistance in maintaining proper posture. FDA UDI
- Model / Reference
- NE1 FDA UDI
- Description
- It is intended for use in correcting improper posture, such as hunching or slouching, and improving overall body alignment. It is suitable for both adults and children who need assistance in maintaining proper posture. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06950715504413 FDA UDI
- FDA Product Code
- IPT FDA UDI
- GMDN Term
- Lumbar spine orthosis 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Lumbar spine orthosis
cofoe by Cofoe Medical Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Cofoe Medical Technology Co., Ltd.
Sources (1)
- FDA UDI 8a4a5504-f770-4821-9b66-866190e3a936 33 fields · synced Jun 6, 2026