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Intellinetix 07232

by Brownmed, Inc.

Ref 07232Model Large

Intellinetix 07232 is a circulatory/musculoskeletal vibration therapy unit (EU MDR Class I; FDA Class I; FDA product code ISA, Massager, Therapeutic, Electric) made by Brownmed, Inc., registered in EUDAMED on 27 May 2026 (Basic UDI-DI 082161INTELLIVGLGPN) and listed in FDA GUDID since 12 Aug 2020 (UDI-DI 00082161072324), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number082161INTELLIVGLGPN Basic UDI-DI 00082161072324UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00082161072324 UDI-DI Date12 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 082161INTELLIVGLGPN registered 27 May 2026 Active
  • FDA GUDID UDI-DI 00082161072324 listed 12 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00082161072324
  2. Registered EUDAMED 082161INTELLIVGLGPN

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  • Withdrawn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
Vibrating Glove EUDAMED
Intellinetix GUDID
Generic name
Circulatory/musculoskeletal vibration therapy unit, hand-held
Device name
Intellinetix® Vibrating Glove
Model / reference
07232, Large
Primary DI / UDI-DI
00082161072324
Basic UDI-DI
082161INTELLIVGLGPN
FDA product code
ISA
EMDN code
Z120601 Electrotherapy equipment (included tens)
GMDN term
Circulatory/musculoskeletal vibration therapy unit, hand-held
Device class
Class I
Regulation number
890.5660
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Circulatory/musculoskeletal vibration therapy unit, hand-held

Similar devices in this category

Other devices filed under ELECTROTHERAPY EQUIPMENT (INCLUDED TENS).

Other devices from Brownmed, Inc.

See all devices from Brownmed, Inc. →

Properties

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