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Osito Ast-301

by Shenzhen Osto Technology Co., Ltd.

Osito Ast-301 is a Class II device made by Shenzhen Osto Technology Co., Ltd., cleared under FDA 510(k) K182136 on 10 Oct 2019 and listed in FDA GUDID since 25 Jun 2020 (UDI-DI 06950940801400), 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) K182136

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 Number06950940801400 UDI-DI Date25 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182136 Date10 Oct 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182136 decided 10 Oct 2019 Active
  • FDA GUDID UDI-DI 06950940801400 listed 25 Jun 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182136
  2. Listed FDA GUDID 06950940801400

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Osito
Generic name
Acupuncture electrical stimulation system
Model / reference
AST-301
Primary DI / UDI-DI
06950940801400
510(k) Number
FDA product code
NGX, NUH
GMDN term
Acupuncture electrical stimulation system
Device class
Class II
Regulation number
890.5850, 882.5890
GUDID distribution status
In Commercial Distribution

Related devices

Category: Acupuncture electrical stimulation system

Cleared under the same submission (K182136)

Similar devices

Also classified as Acupuncture electrical stimulation system.

Similar devices

Other devices filed under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Other devices from Shenzhen Osto Technology Co., Ltd.

  • Ast-646

    Class II

  • Ast-805B

    Class II

  • Ast-622

    Class II

  • Osito Ast-2012A

    Class II

See all devices from Shenzhen Osto Technology Co., Ltd. →

Properties

  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)