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Electronic Muscle Stimulator

by Shenzhen OSTO Medical Technology Company Limited 26 variants

Part of a family of 52 devices: see the family page

Ref AST-2011B

Electronic Muscle Stimulator (AST-2011B) is a device classified as Class IIa in the EU and Class II in the US made by Shenzhen OSTO Medical Technology Company Limited, registered in EUDAMED on 26 Dec 2024 (Basic UDI-DI 695094080001GT), cleared under FDA 510(k) K172837 on 26 Nov 2018 and listed in FDA GUDID since 15 Jul 2020 (UDI-DI 06950940801479), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172837

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number695094080001GT Basic UDI-DI 06950940801479UDI-DIDate26 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06950940801479 UDI-DI Date15 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172837 Date26 Nov 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 695094080001GT registered 26 Dec 2024 Active
  • FDA 510(k) K172837 decided 26 Nov 2018 Active
  • FDA GUDID UDI-DI 06950940801479 listed 15 Jul 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172837
  2. Listed FDA GUDID 06950940801479
  3. Registered EUDAMED 695094080001GT

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Osito
Generic name
Acupuncture electrical stimulation system
Device name
Electronic Muscle Stimulator
Model / reference
AST-2011B
Primary DI / UDI-DI
06950940801479
Basic UDI-DI
695094080001GT
510(k) Number
FDA product code
NGX, NUH
EMDN code
Z12062801 Muscle reinforcement stimulators for innervated muscles
GMDN term
Acupuncture electrical stimulation system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
890.5850, 882.5890
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CN-MF-000022960
Authorised representative
phoenix Medtech GmbH DE-AR-000007996

Similar devices in this category

Other devices filed under MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES.

Other devices from Shenzhen OSTO Medical Technology Company Limited

See all devices from Shenzhen OSTO Medical Technology Company Limited →

Properties

  • Reusable
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (21, all answered No)