BOXOUT, LLC

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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) (9) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (1)

Premarket Exempt

Yes No

Clear

TENSRX - 00815991020346 Catalog Number : 615

Device Description : TENSRX SELF ADHESIVE ELECTRODE 2X2, FABRIC BACKING, 500/CASE

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

TENSRX - 00815991020353 Catalog Number : NPPELE615

Device Description : TENSRX SELF ADHESIVE ELECTRODE 2X2, FABRIC BACKING, 520/CASE

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BodyMed - 00815991020377 Catalog Number : ZZAEV810

Device Description : Fully digital BodyMed TENS unit, ZZAEV810, 10 programs, includes a carrying case Fully digital BodyMed TENS unit, ZZAEV810, 10 programs, includes a carrying case, an adapter and two 9 V batteries

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

BodyMed - 00815991020551 Catalog Number : CUS111

Device Description : BODYMED SELF ADHESIVE ELECTRODE 2X2, FABRIC BACKING, 520/CASE

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

BodyMed - 00815991020575 Catalog Number : NPP606U10

Device Description : BODYMED SELF-ADHERING ELECTRODES, FABRIC BACK, 2" X 4" OVAL, SOLD BY 10 PACKS

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BodyMed - 00815991020582 Catalog Number : NPP609U10

Device Description : BODYMED 3" X 5" RECTANGULAR CLOTH BACK CARBON ELECTRODE, LATEX FREE, 2/PACK, SOL BODYMED 3" X 5" RECTANGULAR CLOTH BACK CARBON ELECTRODE, LATEX FREE, 2/PACK, SOLD BY 10 PACKS

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

RESERV - 00815991021466 Catalog Number : NPP822U10

Device Description : SELF-ADHERING TENS ELECTRODES, 2 INCHES BY 2 INCHES. 4PCS.

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

BODYMED - 00815991021664 Catalog Number :

Device Description : CARBON ELECTRODE, 2.5" ROUND. 1PC/BAG

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

BODYMED - 00815991021671 Catalog Number :

Device Description : CARBON ELECTRODE, 3.3" ROUND. 1PC/BAG

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

BODYMED - 00815991021688 Catalog Number :

Device Description : CARBON ELECTRODE, 3.75" ROUND. 1PC/BAG

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

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