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Perfect EMS

by TensCare Ltd

Ref K-PEMS

Perfect EMS (K-PEMS) is a medical device (EU MDR Class IIa; FDA Class II; EMDN category muscle reinforcement stimulators for innervated muscles) made by TensCare Ltd, registered in EUDAMED on 4 Jun 2024 (Basic UDI-DI 5033435K00045ZL), cleared under FDA 510(k) K200694 on 4 Jun 2021 and listed in FDA GUDID since 31 Aug 2023 (UDI-DI 05033435131419), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200694↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5033435K00045ZL Basic UDI-DI 05033435131419UDI-DIDate4 Jun 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number05033435131419 UDI-DI Date31 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK200694 Date4 Jun 2021IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5033435K00045ZL registered 4 Jun 2024 Active
  • FDA 510(k) K200694 decided 4 Jun 2021 Active
  • FDA GUDID UDI-DI 05033435131419 listed 31 Aug 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200694
  2. Listed FDA GUDID 05033435131419
  3. Registered EUDAMED 5033435K00045ZL

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
Perfect EMS EUDAMED
TensCare GUDID
Generic name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / Ref / Catalog
K-PEMS, Perfect EMS
Primary DI / UDI-DI
05033435131419
Basic UDI-DI
5033435K00045ZL
510(k) Number
FDA product code
NGX, NUH
EMDN code
Z12062801 Muscle reinforcement stimulators for innervated muscles
GMDN term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
890.5850, 882.5890
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
Perfect EMS is a medical device designed to be used in the home healthcare environment to improve muscle tone and bulk, as well as provide symptomatic relief and management of acute or chronic localised pain and muscle pain. It 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-PEMS
GUDID
Perfect EMS
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
UK-PR-000039358

Similar devices in this category

Other devices filed under MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES.

Other devices from TensCare Ltd

See all devices from TensCare Ltd →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)