FKA DISTRIBUTING CO., LLC

Address:12215 Holly St.,Riverside,CA,92509,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) (9) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1)

Premarket Exempt

No Yes

Clear

BROOKSTONE - 00031262094346 Catalog Number :

Device Description : Cordless Shiatsu Neck and Back Massager with Heat

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

BROOKSTONE - 00031262094360 Catalog Number :

Device Description : MAX Single-Node Percussion Massager

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

BROOKSTONE - 00031262094377 Catalog Number :

Device Description : Cordless Active Sport Massager

Device Class :

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

BROOKSTONE - 00031262094384 Catalog Number :

Device Description : MAX 2 Dual-Node Percussion Massager

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

BROOKSTONE - 00031262094391 Catalog Number :

Device Description : MAX2 Cordless Dual-Node Percussion Massager

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

BROOKSTONE - 00031262094407 Catalog Number :

Device Description : Cordless Personal Massager

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

BROOKSTONE - 00031262094414 Catalog Number :

Device Description : FS1 Shiatsu Foot Massager with Heat

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

Brookstone® - 00031262094728 Catalog Number : B-BPW-1000

Device Description : Wrist Blood Pressure Monitor

Device Class : 2

Duns Number: 183280973

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262094797 Catalog Number :

Device Description : CORDLESS BODY WRAP WITH VIBRATION & HEAT

Device Class : 1

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262095190 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

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