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Low-frequency Multi-function physiotherapy instrument

by Shenzhen Osto Technology Co., Ltd.

510(k) K172837

Low-frequency Multi-function physiotherapy instrument is a Class II device made by Shenzhen Osto Technology Co., Ltd., cleared under FDA 510(k) K172837 on 26 Nov 2018, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK172837 Date26 Nov 2018ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NUH
Device class
Class II
Regulation
21 CFR Part 882.5890
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K172837

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K172837
UDI-DISize and differences
AST-2011A
Shenzhen Osto Technology Co., Ltd.
AST-2011A06950940802773 —On the market
AST-802B
Shenzhen Osto Technology Co., Ltd.
AST-802B06950940802582 —On the market
OSITO AST-2011B
Shenzhen Osto Technology Co., Ltd.
AST-2011B06950940801479 —On the market
OSITO AST-802B
Shenzhen Osto Technology Co., Ltd.
AST-802B06950940801523 —On the market

Similar devices

Other devices filed under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

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. →