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 - 00850012532408 Catalog Number : F-0100-30

Device Description : Dayspring Wearable Device - Medium Arm Garment, Medium Arm Liner, X- Large Gaun Dayspring Wearable Device - Medium Arm Garment, Medium Arm Liner, X- Large 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 - 00850012532415 Catalog Number : F-0100-32

Device Description : Dayspring Wearable Device - Medium Arm Garment, X-Large Arm Liner, X- Large Gau Dayspring Wearable Device - Medium Arm Garment, X-Large Arm Liner, X- Large 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 - 00850012532422 Catalog Number : F-0100-31

Device Description : KIT, DAYSPRING, F-0100-31

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532439 Catalog Number : F-0100-33

Device Description : Dayspring Wearable Device - Long Arm Garment, Small Arm Liner, Small Gauntlet, Dayspring Wearable Device - Long Arm Garment, Small 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 - 00850012532446 Catalog Number : F-0100-34

Device Description : Dayspring Wearable Device - Long Arm Garment, Medium Arm Liner, Small Gauntlet, Dayspring Wearable Device - Long 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 - 00850012532453 Catalog Number : F-0100-35

Device Description : KIT, DAYSPRING, F-0100-35

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532460 Catalog Number : F-0100-36

Device Description : Dayspring Wearable Device - Long Arm Garment, X-Large Arm Liner, Small Gauntlet Dayspring Wearable Device - Long 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 - 00850012532477 Catalog Number : F-0100-38

Device Description : Dayspring Wearable Device - Long Arm Garment, Medium Arm Liner, Medium Gauntlet Dayspring Wearable Device - Long 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 - 00850012532484 Catalog Number : F-0100-37

Device Description : Dayspring Wearable Device - Long Arm Garment, Small Arm Liner, Medium Gauntlet, Dayspring Wearable Device - Long Arm Garment, Small 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 - 00850012532491 Catalog Number : F-0100-40

Device Description : Dayspring Wearable Device - Long Arm Garment, X-Large Arm Liner, Medium Gauntle Dayspring Wearable Device - Long 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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