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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 K201559
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 Received06/10/2020
Decision Date 10/02/2020
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
Predetermined Change
Control Plan Authorized		 No
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