BETTER BASICS, 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

Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (3) Analyzer, Body Composition (MNW) (2) Oximeter (DQA) (1) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

No Yes

Clear

Body fat scale - 00817746020304 Catalog Number :

Device Class :

Duns Number: 013029698

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

Body fat scale - 00817746020335 Catalog Number :

Device Class :

Duns Number: 013029698

Premarket Exempt : Yes

Product Code : MNW

Prescription Use : No

Device Count : 1

Pulse Massager - 00817746020366 Catalog Number :

Device Class :

Duns Number: 013029698

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Pulse Massager - 00817746020397 Catalog Number :

Device Class :

Duns Number: 013029698

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Pulse Massager - 00817746020915 Catalog Number :

Device Class :

Duns Number: 013029698

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Pulse Oximeter - 00817746021226 Catalog Number :

Device Class : 2

Duns Number: 013029698

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Fever Thermometer - 00817746026665 Catalog Number :

Device Class : 2

Duns Number: 013029698

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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