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MR4 MR4 Activ G

by Multi Radiance Medical

MR4 MR4 Activ G (U600-300G) is a Class II device made by Multi Radiance Medical, cleared under FDA 510(k) K080102 on 20 Aug 2008 and listed in FDA GUDID since 30 Sep 2016 (UDI-DI 00852556007183), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K080102

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00852556007183 UDI-DI Date30 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK080102 Date20 Aug 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K080102 decided 20 Aug 2008 Active
  • FDA GUDID UDI-DI 00852556007183 listed 30 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K080102
  2. Listed FDA GUDID 00852556007183

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MR4
Generic name
Musculoskeletal infrared phototherapy unit, non-wearable
Model / Ref / Catalog
MR4 Activ G, U600-300G
Primary DI / UDI-DI
00852556007183
510(k) Number
FDA product code
ILY
GMDN term
Musculoskeletal infrared phototherapy unit, non-wearable
Device class
Class II
Regulation number
890.5500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Musculoskeletal infrared phototherapy unit, non-wearable

Cleared under the same submission (K080102)

and 6 more cleared under K080102

Similar devices

Other devices filed under FDA product code ILY (Lamp, Infrared, Therapeutic Heating).

Other devices from Multi Radiance Medical

See all devices from Multi Radiance Medical →

Properties

  • Over-the-counter
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)