BEAR DOWN CONSULTING

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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

Electrode, Cutaneous (GXY) (3) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (3) Media, Electroconductive (GYB) (2) Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) (1)

Premarket Exempt

No Yes

Clear

PURE ENRICHMENT - B311PEPULSEPRO0 Catalog Number :

Device Description : TENS UNIT

Device Class : 2

Duns Number: 040869867

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

PURE ENRICHMENT - B311PEPULSERT0 Catalog Number :

Device Class :

Duns Number: 040869867

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

PURE ENRICHMENT - B311PETENSPAD0 Catalog Number :

Device Description : ELECTRODE PADS

Device Class :

Duns Number: 040869867

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

PURE ENRICHMENT - B311PETNEMHT0 Catalog Number :

Device Class :

Duns Number: 040869867

Premarket Exempt : No

Product Code : NUH, NGX

Prescription Use : No

Device Count : 1

PURE ENRICHMENT - B311PETNEMPD2 Catalog Number :

Device Description : Wired TENS+EMS+HEAT Replacement Gel Pads 2 sets

Device Class :

Duns Number: 040869867

Premarket Exempt : No

Product Code : GXY, GYB

Prescription Use : No

Device Count : 1

PURE ENRICHMENT - B311PETNEMPD5 Catalog Number :

Device Description : Wired TENS+EMS+HEAT Replacement Gel Pads

Device Class :

Duns Number: 040869867

Premarket Exempt : No

Product Code : GXY, GYB

Prescription Use : No

Device Count : 1

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