Koya Medical, Inc.

Address:2461 Peralta St.,Oakland,CA,94607,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

SLEEVE, LIMB, COMPRESSIBLE (JOW) (10)

Premarket Exempt

Yes

Clear

Koya Medical - 00850012532101 Catalog Number : F-0002-01

Device Description : Dayspring Controller

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532118 Catalog Number : F-0006-01

Device Description : Dayspring Charger

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532125 Catalog Number : F-0100-01

Device Description : KIT, DAYSPRING, F-0100-01

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532132 Catalog Number : F-0100-02

Device Description : Dayspring Wearable Device - Short Arm Garment, Medium Arm Liner, Small Gauntlet Dayspring Wearable Device - Short Arm Garment, Medium Arm Liner, Small Gauntlet, Dayspring Controller, and Dayspring Charger

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532149 Catalog Number : F-0100-03

Device Description : Dayspring Wearable Device - Short Arm Garment, Large Arm Liner, Small Gauntlet, Dayspring Wearable Device - Short Arm Garment, Large Arm Liner, Small Gauntlet, Dayspring Controller, and Dayspring Charger

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532156 Catalog Number : F-0100-04

Device Description : Dayspring Wearable Device - Short Arm Garment, X-Large Arm Liner, Small Gauntle Dayspring Wearable Device - Short Arm Garment, X-Large Arm Liner, Small Gauntlet, Dayspring Controller, and Dayspring Charger

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532163 Catalog Number : F-0100-05

Device Description : KIT, DAYSPRING, F-0100-05

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532170 Catalog Number : F-0100-06

Device Description : Dayspring Wearable Device - Short Arm Garment, Medium Arm Liner, Medium Gauntle Dayspring Wearable Device - Short Arm Garment, Medium Arm Liner, Medium Gauntlet, Dayspring Controller, and Dayspring Charger

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532187 Catalog Number : F-0100-07

Device Description : Dayspring Wearable Device - Short Arm Garment, Large Arm Liner, Medium Gauntlet Dayspring Wearable Device - Short Arm Garment, Large Arm Liner, Medium Gauntlet, Dayspring Controller, and Dayspring Charger Copy

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532194 Catalog Number : F-0100-08

Device Description : Dayspring Wearable Device - Short Arm Garment, X-Large Arm Liner, Medium Gauntl Dayspring Wearable Device - Short Arm Garment, X-Large Arm Liner, Medium Gauntlet, Dayspring Controller, and Dayspring Charger

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

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