Identity
- Trade Name
- Positioning Cap FDA UDI
- Generic Name
- Head marking cap FDA UDI
- Model / Reference
- Lycra-10-20 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971538580286 FDA UDI
- 510(k) Number
- K230735 FDA UDI
- FDA Product Code
- FYF FDA UDI
- GMDN Term
- Head marking cap FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Head marking cap
Positioning Cap by Shenzhen Yingzhi Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K230735 also covers:
- TMS Coil — Shenzhen Yingzhi Technology Co., Ltd.
- TMS Coil — Shenzhen Yingzhi Technology Co., Ltd.
- TMS Coil — Shenzhen Yingzhi Technology Co., Ltd.
- TMS Coil — Shenzhen Yingzhi Technology Co., Ltd.
- TMS Coil — Shenzhen Yingzhi Technology Co., Ltd.
- TMS Coil Cooler — Shenzhen Yingzhi Technology Co., Ltd.
- TMS Coil Cooler — Shenzhen Yingzhi Technology Co., Ltd.
- Trolley — Shenzhen Yingzhi Technology Co., Ltd.
- Ultimate rTMS — Shenzhen Yingzhi Technology Co., Ltd.
- Ultimate rTMS — Shenzhen Yingzhi Technology Co., Ltd.
- Ultimate rTMS — Shenzhen Yingzhi Technology Co., Ltd.
- Ultimate rTMS — Shenzhen Yingzhi Technology Co., Ltd.
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
- Shenzhen Yingzhi Technology Co., Ltd.
Sources (1)
- FDA UDI f0335250-783b-4223-a3b7-fe9647b4d2b7 33 fields · synced Jun 1, 2026