BIOMEDICAL LIFE SYSTEMS, INC.

Address:1954 Kellogg Avenue,Carlsbad,CA,92008,US

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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) (6) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (3) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (1)

Premarket Exempt

Clear

BioStim 2.5" oval pigtail electrode - 00850706007205 Catalog Number : EEOV150250MW

Device Description : oval pigtail electrodes

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Bio Knit Conductive cuff - 00850706007236 Catalog Number : GAR888

Device Description : garment cuff

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioKnit Conductive KNEE - 00850706007298 Catalog Number : GAR130

Device Description : universal size sleeve

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

2" x 2" pitail electrode - 00857771003002 Catalog Number : EERC200M

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Rebound - 00857771003019 Catalog Number : KBTR

Device Description : Rebound Health 1/bx

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Rebound refill kit - 00857771003026 Catalog Number : SBTR200

Device Description : ea

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

2" x 4" oval pigtail electrodes ea - 00857771003064 Catalog Number : EEOV200400M

Device Description : ea

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

BioStim Plus - 00857771003071 Catalog Number : KBSP

Device Class :

Duns Number: 116956807

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

BioStim SD - 00857771003088 Catalog Number : KBSD

Device Class :

Duns Number: 116956807

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Impulse 3000 - 00857771003095 Catalog Number : KIM3

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

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