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TMS Coil BY90B

by Shenzhen Yingzhi Technology Co., Ltd.

TMS Coil BY90B 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 14 Jun 2024 (UDI-DI 06971538581061), active as of 22 Oct 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 22 Oct 2026

Documents

510(k) K230735

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06971538581061 UDI-DI Date14 Jun 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK230735 Date13 Sep 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K230735 decided 13 Sep 2023 Active
  • FDA GUDID UDI-DI 06971538581061 listed 14 Jun 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K230735
  2. Listed FDA GUDID 06971538581061

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TMS Coil
Generic name
Magnetic neural stimulation system
Model / reference
BY90B
Primary DI / UDI-DI
06971538581061
510(k) Number
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)