FDA 510(k)

HAL for Medical Use (Lower Limb Type)

K-Number: K171909 · 2017-12-17

Decision Date2017-12-17

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 2017-12-17 under approval number K171909. 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 2017-12-17. It is manufactured by Cyberdyne, Inc.. The 510(k) number is K171909.

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 2017-12-17, under approval number K171909.

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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Related PubMed Literature

PMID: 34249562 Trends in Diagnosis and Treatment of Sacroiliac Joint Pathology Over the Past 10 Years: Review of Scientific Evidence for New Devices for Sacroiliac Joint Fusion. Cureus (2021) PMID: 28533700 Risk management and regulations for lower limb medical exoskeletons: a review. Medical devices (Auckland, N.Z.) (2017)

Other Devices by Cyberdyne, Inc.

K201559HAL for Medical Use(Lower Limb type) K233695Medical HAL Lower Limb Type (HAL-ML)

Related Devices (Code: PHL)

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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.