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iTouch Sure

by TensCare Ltd

Ref K-ITS

iTouch Sure (K-ITS) is a medical device (EU MDR Class IIa; FDA Class II; FDA product code KPI, Stimulator, Electrical, Non-Implantable, For Incontinence; EMDN category pelvic floor rehabilitation devices) made by TensCare Ltd, registered in EUDAMED on 5 Feb 2024 (Basic UDI-DI 5033435K00030Z7), cleared under FDA 510(k) K103698 on 21 Jun 2011 and listed in FDA GUDID since 31 Aug 2023 (UDI-DI 05033435070039), 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) K103698

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 Number5033435K00030Z7 Basic UDI-DI 05033435070039UDI-DIDate5 Feb 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number05033435070039 UDI-DI Date31 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK103698 Date21 Jun 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5033435K00030Z7 registered 5 Feb 2024 Active
  • FDA 510(k) K103698 decided 21 Jun 2011 Active
  • FDA GUDID UDI-DI 05033435070039 listed 31 Aug 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K103698
  2. Listed FDA GUDID 05033435070039
  3. Registered EUDAMED 5033435K00030Z7

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  • Withdrawn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
iTouch Sure EUDAMED
TensCare GUDID
Generic name
Perineal orifice incontinence-control electrical stimulation system, home-use
Model / Ref / Catalog
K-ITS, iTouch Sure
Primary DI / UDI-DI
05033435070039
Basic UDI-DI
5033435K00030Z7
510(k) Number
FDA product code
KPI
EMDN code
U070399 Pelvic floor rehabilitation devices - other
GMDN term
Perineal orifice incontinence-control electrical stimulation system, home-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.5320
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
K-ITS
GUDID
iTouch Sure
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
GB-MF-000004156
Authorised representative
Advena Limited MT-AR-000000234

Similar devices in this category

Other devices filed under PELVIC FLOOR REHABILITATION DEVICES - OTHER.

Other devices from TensCare Ltd

See all devices from TensCare Ltd →

Properties

  • Over-the-counter
  • Serial number
Other properties (23, all answered No)