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 - 00850012532002 Catalog Number : F-0010-01

Device Description : Arm Garmet, Dayspring, Short

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532019 Catalog Number : F-0010-02

Device Description : Arm Garmet, Dayspring, Medium

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532026 Catalog Number : F-0010-03

Device Description : Arm Garmet, Dayspring, Long

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532033 Catalog Number : F-0020-01

Device Description : Arm Liner, Small

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532040 Catalog Number : F-0020-02

Device Description : Arm Liner, Medium

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532057 Catalog Number : F-0020-02

Device Description : Arm Liner, Large

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532064 Catalog Number : F-0030-04

Device Description : Gauntlet, X-Large

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532071 Catalog Number : F-0030-03

Device Description : Gauntlet, Large

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532088 Catalog Number : F-0030-02

Device Description : Gauntlet, Medium

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Koya Medical - 00850012532095 Catalog Number : F-0030-01

Device Description : Gauntlet, Small

Device Class : 2

Duns Number: 100673310

Premarket Exempt : Yes

Product Code : JOW

Prescription Use : Yes

Device Count : 1

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