Identity
- Trade Name
- DR-HO'S FDA UDI
- Generic Name
- Wearable cervical spine traction device FDA UDI
- Device Name
- Neck Comforter This product is used for the peripheral fixation of the neck and the longitudinal traction of the cervical vertebra.It is composed by cloth sleeves, three TPU round air bags and inflatable balls.It is mainly through stretching the cervical interspace under the inflatable state, reducing the pressure of the cervical interspace, improving the burden of the ligaments around the cervical vertebra, so that the injured cervical vertebra can get a full rest. FDA UDI
- Model / Reference
- XB-JT1000 FDA UDI
- Description
- Neck Comforter This product is used for the peripheral fixation of the neck and the longitudinal traction of the cervical vertebra.It is composed by cloth sleeves, three TPU round air bags and inflatable balls.It is mainly through stretching the cervical interspace under the inflatable state, reducing the pressure of the cervical interspace, improving the burden of the ligaments around the cervical vertebra, so that the injured cervical vertebra can get a full rest. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970742221497 FDA UDI
- FDA Product Code
- KQZ FDA UDI
- GMDN Term
- Wearable cervical spine traction device FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.5890 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wearable cervical spine traction device
Dr-Ho's by Guangzhou Xinbo Electronic Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wearable cervical spine traction device.
- Cervico2000 — MEDITRAC 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 |
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Manufacturer
- Manufacturer
- Guangzhou Xinbo Electronic Co., Ltd.
Sources (1)
- FDA UDI 021a3228-5854-4a26-bdf2-4e99323fa820 33 fields · synced May 30, 2026