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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)
Cyberdyne Inc.
2-2-1 Gakuen-Minami
tsukuba,  JP 305-0818
Applicant Contact yohei suzuki
Cyberdyne Inc.
2-2-1 Gakuen-Minami
tsukuba,  JP 305-0818
Correspondent Contact yohei suzuki
Regulation Number890.3480
Classification Product Code
Subsequent Product Code
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