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FDA 510(k)

HAL for Medical Use(Lower Limb type)

K-Number: K201559 · 2020-10-02

ApplicantCyberdyne, Inc.
Decision Date2020-10-02
Product CodePHL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HAL for Medical Use(Lower Limb type) is the device name listed in this FDA 510(k) record. The listed applicant is Cyberdyne, Inc.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) 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. The listed applicant is Cyberdyne, Inc.. The 510(k) number is K201559.

When did HAL for Medical Use(Lower Limb type) receive FDA 510(k) clearance?

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

Who is the listed applicant for HAL for Medical Use(Lower Limb type)?

The FDA 510(k) record lists Cyberdyne, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Cyberdyne, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: PHL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260381EveWandercraft SASK250904Atalante XWandercraft SASK241822ReWalk® 7 Personal Exoskeleton (50-20-0005)Rewalk Robotics Ltd. Dba LifewardK233695Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc.K232077Atalante XWandercraft SASK221696ReWalk P6.0Re Walk Robotics , Ltd.

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.

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