AECORMax Body

GUDID 00850001456418

Omm Imports Inc.

Hand-held electric massager
Primary Device ID00850001456418
NIH Device Record Keybfbe7aed-7a9a-4e89-950f-a107276b6989
Commercial Distribution Discontinuation2031-07-01
Commercial Distribution StatusIn Commercial Distribution
Brand NameAECORMax Body
Version Model NumberAEMAX
Company DUNS010000704
Company NameOmm Imports Inc.
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 Usetrue
Lot Batchfalse
Serial Numberfalse
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
GS100850001456418 [Primary]

FDA Product Code

ISAMassager, Therapeutic, Electric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-04
Device Publish Date2022-06-24

Devices Manufactured by Omm Imports Inc.

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00850001456524 - Genesis Prime2024-09-05 Over the counter red/IR device for the treatment of wrinkles.
00850001456531 - Glorifico2024-09-05 Over the counter red/IR device for the treatment of wrinkles.
00850001456555 - Glorifico Plus2024-09-05 Over the counter red/IR device for the treatment of wrinkles.
00850001456647 - Genesis Skye2024-09-05 Over the counter blue LED phototherapy device for the treatment of acne.
00850001456678 - Elevare2024-09-05 Over the counter red/IR device for the treatment of wrinkles.
00850001456685 - Elevare Plus2024-09-05 Over the counter red/IR device for the treatment of wrinkles.
00850001456692 - Elevare Ivory2024-09-05 Over the counter blue LED phototherapy device for the treatment of acne.

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