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CustomCare

by Micro Current Technology, Inc.

Ref S21 CustomCareModel E275, S21

S21 CustomCare is a medical device (EU MDR Class IIa; FDA Class II; FDA product code GZJ, Stimulator, Nerve, Transcutaneous, For Pain Relief; 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, cleared under FDA 510(k) K033253 on 21 Oct 2003 and listed in FDA GUDID since 15 Mar 2018 (UDI-DI 00817076010846), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

7 Jun 2031

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

510(k) K033253

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 Number1000196662 Date8 Jun 2026IssuedStatusActive expires 7 Jun 2031
United StatesGUDID listing GUDID Number00817076010846 UDI-DI Date15 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK033253 Date21 Oct 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081707601TENSAY registered 26 Aug 2025 Active· +1 more in the status table
  • FDA 510(k) K033253 decided 21 Oct 2003 Active
  • FDA GUDID UDI-DI 00817076010846 listed 15 Mar 2018 Listed

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

5 dated events

  1. Cleared FDA 510(k) K033253
  2. Listed FDA GUDID 00817076010846
  3. Registered EUDAMED 081707601TENSAY
  4. Certificate issued EUDAMED 1000196662
  5. 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  • Withdrawn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 · GUDID

Generic name
Analgesic transcutaneous electrical nerve stimulation system
Device name
E275/S21 Transcutaneous Electrical Nerve Stimulation (TENS) Device
Model / Ref / Catalog
E275, S21, S21 CustomCare, MF-91
Primary DI / UDI-DI
00817076010846
Basic UDI-DI
081707601TENSAY
510(k) Number
FDA product code
GZJ
EMDN code
Z120622 Muscle stimulators
GMDN term
Analgesic transcutaneous electrical nerve stimulation system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.5890
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
E275, S21
S21 CustomCare
GUDID
S21
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
US-MF-000038330
Authorised representative
BEXPERTISE SOLUTIONS, S.L. ES-AR-000026896

Similar devices in this category

Other devices filed under MUSCLE STIMULATORS.

Other devices from Micro Current Technology, Inc.

See all devices from Micro Current Technology, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)