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

Pad, Heating, Powered (IRT) (7) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (3)

Premarket Exempt

No Yes

Clear

HOMEDICS - 00031262101501 Catalog Number :

Device Description : 12" X 15" WEIGHTED HEATING PAD

Device Class : 2

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262101518 Catalog Number :

Device Description : 12" X 24" HEATING PAD WITH GEL

Device Class : 2

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262101525 Catalog Number :

Device Description : WEIGHTED GEL HEATING PAD - 12" X 15"

Device Class : 2

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262101532 Catalog Number :

Device Description : WEIGHTED GEL HEATING PAD WITH HEAT

Device Class : 2

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262101549 Catalog Number :

Device Description : WEIGHTED GEL WRAP WITH HEAT

Device Class : 2

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262101556 Catalog Number :

Device Description : XL MASSAGE WRAP WITH HEAT & MASSAGE

Device Class : 2

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262101563 Catalog Number :

Device Description : Premium Arm Blood Pressure Monitor

Device Class : 2

Duns Number: 183280973

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262101570 Catalog Number :

Device Description : Automatic Arm Blood Pressure Monitor

Device Class : 2

Duns Number: 183280973

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262101587 Catalog Number :

Device Description : Premium Wrist Blood Pressure Monitor

Device Class : 2

Duns Number: 183280973

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

HOMEDICS - 00031262101709 Catalog Number :

Device Description : OVERSIZED HEATING PAD

Device Class : 2

Duns Number: 183280973

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

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