FDA 510(k)

HAL for Medical Use(Lower Limb type)

K-Number: K201559 · 2020-10-02

Decision Date2020-10-02

Product CodePHL

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

HAL for Medical Use(Lower Limb type) is a medical device manufactured by Cyberdyne, Inc.. It received FDA 510(k) clearance on 2020-10-02 under approval number K201559. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAL for Medical Use(Lower Limb type)?

HAL for Medical Use(Lower Limb type) is a medical device that received FDA 510(k) clearance on 2020-10-02. It is manufactured by Cyberdyne, Inc.. The 510(k) number is K201559.

When was HAL for Medical Use(Lower Limb type) approved by the FDA?

HAL for Medical Use(Lower Limb type) received FDA 510(k) clearance on 2020-10-02, under approval number K201559.

What company makes HAL for Medical Use(Lower Limb type)?

HAL for Medical Use(Lower Limb type) is manufactured by Cyberdyne, Inc..

What is the FDA product code for HAL for Medical Use(Lower Limb type)?

The FDA product code for HAL for Medical Use(Lower Limb type) is PHL.

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Other Devices by Cyberdyne, Inc.

K171909HAL for Medical Use (Lower Limb Type) K233695Medical HAL Lower Limb Type (HAL-ML)

Related Devices (Code: PHL)

K160987ReWalk(TM)Rewalk Robotics, Inc. K161443Ekso (version 1.1) and Ekso GT (version 1.2)Ekso Bionics, Inc. K143690Ekso (version 1.1) and Ekso GT (version 1.2)Ekso Bionics, Inc. K152416IndegoParker Hannifin Corporation K171909HAL for Medical Use (Lower Limb Type)Cyberdyne, Inc. K171334IndegoParker Hannifin Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.