TMS Coil

by Shenzhen Yingzhi Technology Co., Ltd.

TMS Coil is a Class II device made by Shenzhen Yingzhi Technology Co., Ltd., cleared under FDA 510(k) K230735 on 13 Sep 2023 and listed in FDA GUDID since 21 Dec 2023 (UDI-DI 06971538580149), active as of 8 Jun 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Jun 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 8 Jun 2026.

Regulatory status

as of registry sync 8 Jun 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06971538580149 UDI-DI	Date21 Dec 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK230735	Date13 Sep 2023Decided	StatusActive

Official records

AccessGUDID record UDI-DI 06971538580149
FDA 510(k) database 510(k) number K230735

Across registries

2 registries list this device

FDA 510(k) K230735 decided 13 Sep 2023 Active
FDA GUDID UDI-DI 06971538580149 listed 21 Dec 2023 Listed

Timeline

2 dated events

13 Sep 2023 Cleared FDA 510(k) K230735
21 Dec 2023 Listed FDA GUDID 06971538580149

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Magnetic neural stimulation system
Model / reference: /

Primary DI / UDI-DI: 06971538580149
510(k) Number: K230735
FDA product code: GWF
GMDN term: Magnetic neural stimulation system

Device class: Class II
Regulation number: 882.1870
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)