HAL For Medical Use(Lower Limb Type)

Powered Exoskeleton

Cyberdyne Inc.

The following data is part of a premarket notification filed by Cyberdyne Inc. with the FDA for Hal For Medical Use(lower Limb Type).

Pre-market Notification Details

Device IDK201559
510k NumberK201559
Device Name:HAL For Medical Use(Lower Limb Type)
ClassificationPowered Exoskeleton
Applicant Cyberdyne Inc. 2-2-1 Gakuen-Minami Tsukuba,  JP 305-0818
ContactYohei Suzuki
CorrespondentYohei Suzuki
Cyberdyne Inc. 2-2-1 Gakuen-Minami Tsukuba,  JP 305-0818
Product CodePHL  
CFR Regulation Number890.3480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-10
Decision Date2020-10-02

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