H ROBOTICS INC.

Address:402,Yeonsu-gu Incheon,KR

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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

Exerciser, Powered (BXB) (10)

Premarket Exempt

Yes

Clear

rebless - 08800101600015 Catalog Number :

Device Class : 1

Duns Number: 695126303

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

rebless - 08800101600022 Catalog Number :

Device Description : pad set

Device Class : 1

Duns Number: 695126303

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

rebless - 08800101600039 Catalog Number :

Device Description : strap set

Device Class : 1

Duns Number: 695126303

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

rebless - 08800101600046 Catalog Number :

Device Description : buckle

Device Class : 1

Duns Number: 695126303

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

rebless - 08800101600053 Catalog Number :

Device Description : hand support

Device Class : 1

Duns Number: 695126303

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

rebless - 08800101600060 Catalog Number :

Device Description : adapter

Device Class : 1

Duns Number: 695126303

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

rebless - 08800101600077 Catalog Number :

Device Description : Adapter cable

Device Class : 1

Duns Number: 695126303

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

rebless - 08800101600084 Catalog Number :

Device Description : Power switch

Device Class : 1

Duns Number: 695126303

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

rebless - 08800101600091 Catalog Number :

Device Description : Actuator socket cover

Device Class : 1

Duns Number: 695126303

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

rebless - 08800101600107 Catalog Number :

Device Description : T-wrench

Device Class : 1

Duns Number: 695126303

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

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