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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Exoskeleton
510(k) Number K171909
Device Name HAL for Medical Use (Lower Limb Type)
Applicant
CYBERDYNE Inc.
2-2-1 Gakuen-Minami
Tsukuba,  JP 305-0818
Applicant Contact Yohei Suzuki
Correspondent
CYBERDYNE Inc.
2-2-1 Gakuen-Minami
Tsukuba,  JP 305-0818
Correspondent Contact Yohei Suzuki
Regulation Number890.3480
Classification Product Code
PHL  
Subsequent Product Code
HCC  
Date Received06/26/2017
Decision Date 12/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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