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Intellinetix 07240

by Brownmed, Inc.

Ref 07240Model Universal

Intellinetix 07240 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 082161INTELLIVUW4B) and listed in FDA GUDID since 12 Aug 2020 (UDI-DI 00821610724168), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number082161INTELLIVUW4B Basic UDI-DI 00821610724168UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821610724168 UDI-DI Date12 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 082161INTELLIVUW4B registered 27 May 2026 Active
  • FDA GUDID UDI-DI 00821610724168 listed 12 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00821610724168
  2. Registered EUDAMED 082161INTELLIVUW4B

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  • Withdrawn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
Intellinetix® EUDAMED
Intellinetix GUDID
Generic name
Circulatory/musculoskeletal vibration therapy unit, hand-held
Device name
Intellinetix® Heated Therapy Universal Wrap
Model / reference
07240, Universal
Primary DI / UDI-DI
00821610724168 EUDAMED
00082161072409 GUDID
Basic UDI-DI
082161INTELLIVUW4B
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00821610724168
GUDID
00082161072409

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00821610724168; FDA GUDID lists 00082161072409), so their flags are not compared.

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)