ANODYNE THERAPY,LLC

GUDID 00859101006103

ANODYNE THERAPY, L.L.C.

Musculoskeletal infrared phototherapy unit, non-wearable
Primary Device ID00859101006103
NIH Device Record Keybcc6a75d-753b-454f-9fac-2667b2cfc51c
Commercial Distribution StatusIn Commercial Distribution
Brand NameANODYNE THERAPY,LLC
Version Model Number120-2 LARGE THERAPY PADS
Company DUNS148751568
Company NameANODYNE THERAPY, L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100859101006103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-03-29
Device Publish Date2021-03-19

Devices Manufactured by ANODYNE THERAPY, L.L.C.

00859101006103 - ANODYNE THERAPY,LLC2021-03-29
00859101006103 - ANODYNE THERAPY,LLC2021-03-29
00859101006004 - Anodyne Therapy2018-07-06
00859101006011 - Anodyne Therapy2018-07-06
00859101006028 - Anodyne Therapy2018-07-06
00859101006035 - Anodyne Therapy2018-07-06
00859101006042 - Anodyne Therapy2018-07-06
00859101006097 - Anodyne Therapy2018-07-06
00859101006059 - Anodyne Therapy2018-05-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.