FDA 510(k) Application Details - K233695

Device Classification Name	More FDA Info for this Device
510(K) Number	K233695
Device Name	Medical HAL Lower Limb Type (HAL-ML)
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	11/17/2023
Decision Date	05/07/2024
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