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TENS One

by TensCare Ltd

Ref K-TENSONE

TENS One (K-TENSONE) is a medical device (EU MDR Class IIa; FDA Class II; FDA product code NUH, Stimulator, Nerve, Transcutaneous, Over-The-Counter; EMDN category muscle stimulators) made by TensCare Ltd, registered in EUDAMED on 22 Aug 2024 (Basic UDI-DI 5033435K00075DSY) and listed in FDA GUDID since 5 Aug 2019 (UDI-DI 05033435136339), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5033435K00075DSY Basic UDI-DI Date22 Aug 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number05033435136339 UDI-DI Date5 Aug 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5033435K00075DSY registered 22 Aug 2024 Active
  • FDA GUDID UDI-DI 05033435136339 listed 5 Aug 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05033435136339
  2. Registered EUDAMED 5033435K00075DSY

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
TENS One EUDAMED
Tenscare GUDID
Generic name
Analgesic transcutaneous electrical nerve stimulation system
Model / Ref / Catalog
K-TENSONE, TENS One
Primary DI / UDI-DI
05033435136339, 05033435134045
Basic UDI-DI
5033435K00075DSY, 5033435E00075XF
FDA product code
NUH
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
System or procedure pack
Procedure pack
EU registration type
Standard device
System or procedure pack
EU market of registration
Denmark
Medical purpose
TENS One is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. The device is suitable for use by all who can control the device and understand the instructions.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
K-TENSONE
GUDID
TENS One
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 MUSCLE STIMULATORS.

Other devices from TensCare Ltd

See all devices from TensCare Ltd →

Properties

  • Over-the-counter
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)