Omm Imports Inc.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Massager, Therapeutic, Electric (ISA) (2) Lamp, Infrared, Therapeutic Heating (ILY) (1) Light Based Over The Counter Wrinkle Reduction (OHS) (1)

Premarket Exempt

No Yes

Clear

AECOR 250 Neck Pro - 00850001456234 Catalog Number :

Device Class : 1

Duns Number: 010000704

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

Relaxatio - 00850001456357 Catalog Number :

Device Description : Over the counter Red/IR LED Heating device for minor aches and pains, temporary Over the counter Red/IR LED Heating device for minor aches and pains, temporary increase in circulation.

Device Class : 2

Duns Number: 010000704

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

AECORMax Body - 00850001456418 Catalog Number :

Device Class : 1

Duns Number: 010000704

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

Genesis Z - 00850001456456 Catalog Number :

Device Class : 2

Duns Number: 010000704

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

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