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) Interferential Current Therapy (LIH) (3) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (3) Stimulator, Muscle, Powered (IPF) (2)

Premarket Exempt

Clear

BioStim INF - 00857771003217 Catalog Number : KBSI

Device Class :

Duns Number: 116956807

Premarket Exempt : No

Product Code : LIH

Prescription Use : Yes

Device Count : 1

BioStim M7 - 00857771003224 Catalog Number : KBSM7

Device Class :

Duns Number: 116956807

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

QuadStar II - 00857771003231 Catalog Number : KQST

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : LIH, IPF, GZJ

Prescription Use : Yes

Device Count : 1

pre-gelled black carbon electrode 1.5" x 1.75" - 00857771003248 Catalog Number : L00035

Device Description : (10 pouches/bag)

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

QuadStar Elite - 00857771003255 Catalog Number : KQSE

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : LIH, IPF, GZJ

Prescription Use : Yes

Device Count : 1

1.5" x 2.5" oval pigtail electrode - 00857771003262 Catalog Number : EEOV150250M

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

3.75" x 6" butterfly electrode - 00857771003279 Catalog Number : EBTF357600M

Device Description : ea

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

2" round electrode - 00857771003286 Catalog Number : EERD200M

Device Description : ea

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

2 x 2 electrode 2 pk - 00857771003293 Catalog Number : EESQ2PK

Device Description : 2 pk

Device Class : 2

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

2.25" x 2.50" electrode - 00857771003309 Catalog Number : EDRC225250

Device Description : 20 per pouch

Device Class :

Duns Number: 116956807

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

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