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

Nebulizer (Direct Patient Interface) (CAF) (5) Massager, Therapeutic, Electric (ISA) (3) Stimulator, Muscle, Powered (IPF) (3) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (3) Pad, Heating, Powered (IRT) (1)

Premarket Exempt

Yes No

Clear

BodyMed - 00815991023019 Catalog Number : ZZACOMBO

Device Description : BODYMED TENS/EMS/MASSAGER COMBO

Device Class : 1

Duns Number: 066689993

Premarket Exempt : No

Product Code : IPF, GZJ, ISA

Prescription Use : Yes

Device Count : 1

BodyMed - 00815991023026 Catalog Number : ZZACOMBOBDPT1

Device Description : BODYMED TENS/EMS/MASSAGER COMBO WITH BODY PART DIAGRAM

Device Class : 1

Duns Number: 066689993

Premarket Exempt : No

Product Code : IPF, GZJ, ISA

Prescription Use : Yes

Device Count : 1

BodyMed - 00815991023033 Catalog Number : ZZACOMBOBDPT2

Device Description : BODYMED TENS/EMS/MASSAGER COMBO WITH BODY PART DIAGRAM, RECHARGEABLE

Device Class : 1

Duns Number: 066689993

Premarket Exempt : No

Product Code : IPF, GZJ, ISA

Prescription Use : Yes

Device Count : 1

BodyMed - 00815991024191 Catalog Number :

Device Description : BODYMED LED MOIST AND DRY HEATING PAD, WITH AUTO SHUT-OFF AT 2 HOURS. 12" X 15"

Device Class : 2

Duns Number: 066689993

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

BodyMed - 00815991024405 Catalog Number :

Device Description : BodyMed compressor nebulizer system, compact design, with disposible nebulizer k BodyMed compressor nebulizer system, compact design, with disposible nebulizer kit included.

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

BodyMed - 00815991024412 Catalog Number :

Device Description : BODYMED DOG PEDIATRIC COMPRESSOR NEBULIZER SYSTEM, WITH DISPOSIBLE NEBULIZER KIT INCLUDED.

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

BodyMed - 00815991024658 Catalog Number :

Device Description : BODYMED NEBULIZER KIT WITH ADULT MASK, INCLUDING A DISPOSABLE ADULT MASK, 6CC ME BODYMED NEBULIZER KIT WITH ADULT MASK, INCLUDING A DISPOSABLE ADULT MASK, 6CC MEDICATION CUP, AND TUBING.

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

BodyMed - 00815991024665 Catalog Number :

Device Description : BODYMED NEBULIZER KIT WITH MOUTHPIECE, INCLUDING A DISPOSABLE MOUTHPIECE, 6CC ME BODYMED NEBULIZER KIT WITH MOUTHPIECE, INCLUDING A DISPOSABLE MOUTHPIECE, 6CC MEDICATION CUP, AND TUBING.

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

BodyMed - 00815991024672 Catalog Number :

Device Description : BODYMED NEBULIZER KIT WITH PEDIATRIC MASK, INCLUDING A DISPOSABLE PEDIATRIC MASK BODYMED NEBULIZER KIT WITH PEDIATRIC MASK, INCLUDING A DISPOSABLE PEDIATRIC MASK, 6CC MEDICATION CUP, AND TUBING.

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

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