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FDA 510(k)

ORTHOTIC LEG GAIT CORRECTOR DEVICE

K-Number: K800716 · 1980-05-02

ApplicantIpos Luneburg
Decision Date1980-05-02
Product CodeITO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ORTHOTIC LEG GAIT CORRECTOR DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Ipos Luneburg. It received FDA 510(k) clearance on 1980-05-02 under 510(k) number K800716. The device is classified under product code ITO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOTIC LEG GAIT CORRECTOR DEVICE?

ORTHOTIC LEG GAIT CORRECTOR DEVICE is a medical device that received FDA 510(k) clearance on 1980-05-02. The listed applicant is Ipos Luneburg. The 510(k) number is K800716.

When did ORTHOTIC LEG GAIT CORRECTOR DEVICE receive FDA 510(k) clearance?

ORTHOTIC LEG GAIT CORRECTOR DEVICE received FDA 510(k) clearance on 1980-05-02, under 510(k) number K800716.

Who is the listed applicant for ORTHOTIC LEG GAIT CORRECTOR DEVICE?

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

What is the FDA product code for ORTHOTIC LEG GAIT CORRECTOR DEVICE?

The FDA product code for ORTHOTIC LEG GAIT CORRECTOR DEVICE is ITO.

Related Clinical Trials

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.

Other records listing Ipos Luneburg 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.

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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.

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