CYBERDYNE, INC.

Address:2-2-1 Gakuen-minami,Tsukuba Ibaraki,JP

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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

Device, Biofeedback (HCC) (8) Powered Exoskeleton (PHL) (8)

Premarket Exempt

Clear

HAL for Medical Use - 04560340090940 Catalog Number :

Device Description : Number of legs: DoubleLeg length: ShortHip width: Medium

Device Class : 2

Duns Number: 714480766

Premarket Exempt : No

Product Code : HCC, PHL

Prescription Use : Yes

Device Count : 1

HAL for Medical Use - 04560340090957 Catalog Number :

Device Description : Number of legs: DoubleLeg length: MediumHip width: Medium

Device Class : 2

Duns Number: 714480766

Premarket Exempt : No

Product Code : HCC, PHL

Prescription Use : Yes

Device Count : 1

HAL for Medical Use - 04560340090964 Catalog Number :

Device Description : Number of legs: DoubleLeg length: LongHip width: Medium

Device Class : 2

Duns Number: 714480766

Premarket Exempt : No

Product Code : HCC, PHL

Prescription Use : Yes

Device Count : 1

HAL for Medical Use - 04560340090971 Catalog Number :

Device Description : Number of legs: DoubleLeg length: eXtra longHip width: Medium

Device Class : 2

Duns Number: 714480766

Premarket Exempt : No

Product Code : HCC, PHL

Prescription Use : Yes

Device Count : 1

HAL for Medical Use - 04560340091060 Catalog Number :

Device Description : Number of legs: DoubleLeg length: ShortHip width: Wide

Device Class : 2

Duns Number: 714480766

Premarket Exempt : No

Product Code : HCC, PHL

Prescription Use : Yes

Device Count : 1

HAL for Medical Use - 04560340091077 Catalog Number :

Device Description : Number of legs: DoubleLeg length: MediumHip width: Wide

Device Class : 2

Duns Number: 714480766

Premarket Exempt : No

Product Code : HCC, PHL

Prescription Use : Yes

Device Count : 1

HAL for Medical Use - 04560340091084 Catalog Number :

Device Description : Number of legs: DoubleLeg length: LongHip width: Wide

Device Class : 2

Duns Number: 714480766

Premarket Exempt : No

Product Code : HCC, PHL

Prescription Use : Yes

Device Count : 1

HAL for Medical Use - 04560340091091 Catalog Number :

Device Description : Number of legs: DoubleLeg length: eXtra longHip width: Wide

Device Class : 2

Duns Number: 714480766

Premarket Exempt : No

Product Code : HCC, PHL

Prescription Use : Yes

Device Count : 1

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