FDA 510(k)

Medical HAL Lower Limb Type (HAL-ML)

K-Number: K233695 · 2024-05-07

Decision Date2024-05-07

Product CodePHL

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Medical HAL Lower Limb Type (HAL-ML) is a medical device manufactured by Cyberdyne, Inc.. It received FDA 510(k) clearance on 2024-05-07 under approval number K233695. 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 Medical HAL Lower Limb Type (HAL-ML)?

Medical HAL Lower Limb Type (HAL-ML) is a medical device that received FDA 510(k) clearance on 2024-05-07. It is manufactured by Cyberdyne, Inc.. The 510(k) number is K233695.

When was Medical HAL Lower Limb Type (HAL-ML) approved by the FDA?

Medical HAL Lower Limb Type (HAL-ML) received FDA 510(k) clearance on 2024-05-07, under approval number K233695.

What company makes Medical HAL Lower Limb Type (HAL-ML)?

Medical HAL Lower Limb Type (HAL-ML) is manufactured by Cyberdyne, Inc..

What is the FDA product code for Medical HAL Lower Limb Type (HAL-ML)?

The FDA product code for Medical HAL Lower Limb Type (HAL-ML) is PHL.

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Other Devices by Cyberdyne, Inc.

K171909HAL for Medical Use (Lower Limb Type) K201559HAL for Medical Use(Lower Limb type)

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.