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Pointer Excel II ED3988

by Tens Plus Industrial Company

Ref ED3988Model Pointer Excel II

Pointer Excel II ED3988 is a medical device (EU MDR Class IIa; FDA Class II; FDA product code GZJ, Stimulator, Nerve, Transcutaneous, For Pain Relief; EMDN category acupuncture stimulators) made by Tens Plus Industrial Company, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 489707672EXCEQT), cleared under FDA 510(k) K060517 on 19 Jun 2006 and listed in FDA GUDID since 4 Aug 2016 (UDI-DI 14897076723550), 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) K060517

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number489707672EXCEQT Basic UDI-DI 14897076723550UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14897076723550 UDI-DI Date4 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK060517 Date19 Jun 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 489707672EXCEQT registered 7 Oct 2026 Active
  • FDA 510(k) K060517 decided 19 Jun 2006 Active
  • FDA GUDID UDI-DI 14897076723550 listed 4 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K060517
  2. Listed FDA GUDID 14897076723550
  3. Registered EUDAMED 489707672EXCEQT

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  • Withdrawn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
Pointer Excel II
Generic name
Analgesic transcutaneous electrical nerve stimulation system
Device name
Pointer Excel II TENS
Model / Ref / Catalog
ED3988, Pointer Excel II
Primary DI / UDI-DI
14897076723550 EUDAMED
14897076720054 GUDID
Basic UDI-DI
489707672EXCEQT
510(k) Number
FDA product code
GZJ
EMDN code
Z120623 Acupuncture 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
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
14897076723550
GUDID
14897076720054
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 14897076723550; FDA GUDID lists 14897076720054), so their flags are not compared. 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.

Related devices

Category: Analgesic transcutaneous electrical nerve stimulation system

Similar devices in this category

Other devices filed under ACUPUNCTURE STIMULATORS.

Other devices from Tens Plus Industrial Company

See all devices from Tens Plus Industrial Company →

Properties

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