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FDA 510(k) Application Details - K171909
Device Classification Name
More FDA Info for this Device
510(K) Number
K171909
Device Name
HAL for Medical Use (Lower Limb Type)
Applicant
CYBERDYNE Inc.
2-2-1 Gakuen-Minami
Tsukuba 305-0818 JP
Other 510(k) Applications for this Company
Contact
Yohei Suzuki
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PHL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/26/2017
Decision Date
12/17/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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