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AutoCare

by Micro Current Technology, Inc.

Ref E275 AutoCareModel E275, S21

E275 AutoCare is a medical device (EU MDR Class IIa; EMDN category muscle stimulators) made by Micro Current Technology, Inc., registered in EUDAMED on 26 Aug 2025 (Basic UDI-DI 081707601TENSAY) with CE/MDR certificate 1000196662 valid until 7 Jun 2031 and cleared under FDA 510(k) K032653 on 12 Sep 2003, active as of 24 Oct 2026.

Active European Union and United States

CE MDR 510(k)

Valid until

7 Jun 2031

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

510(k) K032653↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000196662 Date8 Jun 2026IssuedStatusActive expires 7 Jun 2031
United StatesFDA 510(k) 510(k) NumberK032653 Date12 Sep 2003IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081707601TENSAY registered 26 Aug 2025 Active· +1 more in the status table
  • FDA 510(k) K032653 decided 12 Sep 2003 Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000196662 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    8 Jun 2026
    Expires
    7 Jun 2031

Timeline

4 dated events

  1. Cleared FDA 510(k) K032653
  2. Registered EUDAMED 081707601TENSAY
  3. Certificate issued EUDAMED 1000196662
  4. Certificate expires EUDAMED 1000196662

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  • Withdrawn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 · 510(k)

Device name
E275/S21 Transcutaneous Electrical Nerve Stimulation (TENS) Device
Model / reference
E275, S21, E275 AutoCare
Primary DI / UDI-DI
00817076012642
Basic UDI-DI
081707601TENSAY
EMDN code
Z120622 Muscle stimulators
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000038330
Authorised representative
BEXPERTISE SOLUTIONS, S.L. ES-AR-000026896

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Other devices filed under MUSCLE STIMULATORS.

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Properties

Other properties (14, all answered No)