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) (5) Pad, Heating, Powered (IRT) (2) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (2) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (1)

Premarket Exempt

Yes No

Clear

BodyMed - 00815802017442 Catalog Number : NPP628

Device Description : BODYMED 1.5" X 2.5" OVAL WHITE FABRIC CARBON ELECTRODE, 4/PK

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BodyMed - 00815802017459 Catalog Number : NPP629

Device Description : BODYMED 2" X 4" OVAL WHITE FOAM CARBON ELECTRODE, 4/PK

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BodyMed - 00815802018524 Catalog Number : GSM600E

Device Description : 2" X 3.5" RECTANGULAR WHITE FABRIC CARBON ELECTRODE, PRIVATE LABEL FOR GOLDEN ST 2" X 3.5" RECTANGULAR WHITE FABRIC CARBON ELECTRODE, PRIVATE LABEL FOR GOLDEN STATE LOGO, 4/PK

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BodyMed - 00815802018715 Catalog Number : ZZHP1427BLK

Device Description : BodyMed Digital Heating Pad 14"x27", black cover

Device Class :

Duns Number: 066689993

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

BodyMed - 00815802018722 Catalog Number : ZZHP1215E

Device Description : BODYMED LED MOIST AND DRY HEATING PAD, 12" X 15"

Device Class :

Duns Number: 066689993

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

BodyMed - 00815802018791 Catalog Number :

Device Description : BODYMED ECONOMY TENS, ANALOG TWO CHANNEL 3 MODE TENS WITH TIMER

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

BodyMed - 00815802018807 Catalog Number : ZZA900

Device Description : BODYMED DIGITAL TENS/EMS/IF COMBO, TWO CHANNEL

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

BodyMed - 00815802018821 Catalog Number : ZZAEV820OTC

Device Description : BODYMED DIGITAL OVER THE COUNTER TENS UNIT

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

BodyMed - 00815802019903 Catalog Number : NPPOTC22

Device Description : BODYMED OVER THE COUNTER SELF-ADHERING ELECTRODE, FABRIC BACK, 2" X 2" SQUARE, 4/PACKAGE

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

BodyMed - 00815802019910 Catalog Number : NPPOTC2IR

Device Description : BODYMED OVER THE COUNTER SELF-ADHERING ELECTRODE, FABRIC BACK, 2" ROUND, 4/PACKAGE

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

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