ONLUX

GUDID 00860013229023

ONLUX Shoulder LED Infrared therapy device

PHYSIOHAB LLC

Blue/red/infrared phototherapy lamp
Primary Device ID00860013229023
NIH Device Record Keyd5c15120-1ca6-40eb-bce1-954fb4f1d3c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameONLUX
Version Model NumberOLS3005
Company DUNS122389660
Company NamePHYSIOHAB LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100860013229023 [Primary]

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-03
Device Publish Date2025-03-26

On-Brand Devices [ONLUX]

00860013229085LED infrared light therapy wrap for amputees
00860013229078LED Infrared therapy wrap for the elbow
00860013229061LED Infrared therapy device for the foot
00860013229054LED Infrared light therapy wrap for the ankle
00860013229047LED Infrared light therapy wrap for the Knee
00860013229023ONLUX Shoulder LED Infrared therapy device
00860013229016LED Infrared Therapy device for the hand
00860013229009LED Infrared therapy device for the lumbar
00860013229030LED Infrared therapy device for the Neck

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