FKA DISTRIBUTING CO., LLC

FKA DISTRIBUTING CO., LLC

Address:3000 N Pontiac Trl,Commerce Township,MI,48390,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

Massager, Therapeutic, Electric (ISA) (10)

Premarket Exempt

No Yes

Clear

HOMEDICS - 00031262066626 Catalog Number :

Device Description : Shiatsu Neck Massager

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262082268 Catalog Number :

Device Description : BUBBLE BLISS ELITE

Device Class :

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262089175 Catalog Number :

Device Description : Cordless percussion body massager

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262089199 Catalog Number :

Device Description : SHIATSU+VIBRATION BODY MASSAGER WITH SOOTHING HEAT

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262092762 Catalog Number :

Device Description : VIBRATION FOOT MASSAGER

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262093516 Catalog Number :

Device Description : Shiatsu & Vibration Neck Massager

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262093523 Catalog Number :

Device Description : VIBRATION NECK MASSAGER

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262093974 Catalog Number :

Device Description : Vibration Neck Massager

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

BROOKSTONE - 00031262094315 Catalog Number :

Device Description : C7 Shiatsu Massaging Seat Topper with Heat

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

BROOKSTONE - 00031262094322 Catalog Number :

Device Description : Cordless Shiatsu Massager with Heat

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

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