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Es-130

by Ito Co., Ltd.

Ref ES-130

Es-130 is a device classified as Class IIa (EU), Unclassified (US) made by Ito Co., Ltd., registered in EUDAMED on 2 Apr 2026 (Basic UDI-DI B-04983087008403), cleared under FDA 510(k) K081943 on 24 Nov 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04983087008403), active as of 22 Oct 2026.

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

CE MDD 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) K081943

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/MDD EUDAMED NumberB-04983087008403 Basic UDI-DI 04983087008403UDI-DIDate2 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04983087008403 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK081943 Date24 Nov 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04983087008403 registered 2 Apr 2026 Active
  • FDA 510(k) K081943 decided 24 Nov 2008 Active
  • FDA GUDID UDI-DI 04983087008403 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K081943
  2. Listed FDA GUDID 04983087008403
  3. Registered EUDAMED B-04983087008403

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Acupuncture electrical stimulation system
Model / Ref / Catalog
ES-130
Primary DI / UDI-DI
04983087008403
Basic UDI-DI
B-04983087008403
510(k) Number
FDA product code
BWK
EMDN code
Z120601 Electrotherapy equipment (included tens)
GMDN term
Acupuncture electrical stimulation system
Device class
Class IIa EUDAMED
U GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
Cyprus
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
U

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

Related devices

Category: Acupuncture electrical stimulation system

Similar devices in this category

Other devices filed under ELECTROTHERAPY EQUIPMENT (INCLUDED TENS).

Other devices from Ito Co., Ltd.

  • D function

    Class II

  • Tm-400

    Class II

  • Es-160

    Class II

  • Es-5200

    Class IIa

See all devices from Ito Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)