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

Pad, Heating, Powered (IRT) (4) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (2) Electrode, Cutaneous (GXY) (1) Interferential Current Therapy (LIH) (1) Stimulator, Muscle, Powered (IPF) (1) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (1)

Premarket Exempt

No Yes

Clear

BodyMed - 00815802010023 Catalog Number : ZZAIF400

Device Description : BODYMED DIGITAL INTERFERENTIAL DUAL CHANNEL WITH 2 MODES

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : LIH

Prescription Use : Yes

Device Count : 1

BodyMed - 00815802010078 Catalog Number : ZZA550

Device Description : BODYMED ANALOG ELECTRICAL MUSCLE SIMULATOR UNIT

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

BodyMed - 00815802010085 Catalog Number :

Device Description : BODYMED LOWER BACK PAIN RELIEF KIT AND ACCESSORIES

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : NUH

Prescription Use : Yes

Device Count : 1

BodyMed - 00815802010092 Catalog Number : ZZA1505

Device Description : BODYMED REPLACEMENT ELECTRODES FOR LOWER BACK PAIN RELIEF SYSTEM, 2" X 2" SQUAR BODYMED REPLACEMENT ELECTRODES FOR LOWER BACK PAIN RELIEF SYSTEM, 2" X 2" SQUARE, LATEX FREE, 4/PACK

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BodyMed - 00815802010108 Catalog Number : ZZA1510

Device Description : BODYMED LOWER BACK PAIN RELIEF KIT AND ACCESSORIES

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : NUH

Prescription Use : Yes

Device Count : 1

BodyMed - 00815802010115 Catalog Number : ZZA45LW

Device Description : BODYMED REPLACEMENT LEAD WIRES, 2/PK, for BODYMED TENS UNIT

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

BodyMed - 00815802010122 Catalog Number : ZZHP1427

Device Description : BodyMed heating pad, 14"x27", white cover

Device Class :

Duns Number: 066689993

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

BodyMed - 00815802010139 Catalog Number : ZZHP1414

Device Description : BODYMED DIGITAL MOIST HEATING PAD, 14" x 14"

Device Class : 2

Duns Number: 066689993

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

BodyMed - 00815802010146 Catalog Number : ZZHP147

Device Description : BODYMED DIGITAL MOIST HEATING PAD, 14" x 7"

Device Class : 2

Duns Number: 066689993

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

BodyMed - 00815802010153 Catalog Number : ZZHP832U

Device Description : BODYMED DIGITAL MOIST HEATING PAD, 8" X 32" U-SHAPED

Device Class : 2

Duns Number: 066689993

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

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