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FDA 510(k)

Biological Feedback and Stimulation System

K-Number: K222201 · 2022-10-21

ApplicantMedlander Medical Technology, Inc.
Decision Date2022-10-21
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Biological Feedback and Stimulation System is the device name listed in this FDA 510(k) record. The listed applicant is Medlander Medical Technology, Inc.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K222201. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biological Feedback and Stimulation System?

Biological Feedback and Stimulation System is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Medlander Medical Technology, Inc.. The 510(k) number is K222201.

When did Biological Feedback and Stimulation System receive FDA 510(k) clearance?

Biological Feedback and Stimulation System received FDA 510(k) clearance on 2022-10-21, under 510(k) number K222201.

Who is the listed applicant for Biological Feedback and Stimulation System?

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

What is the FDA product code for Biological Feedback and Stimulation System?

The FDA product code for Biological Feedback and Stimulation System is IPF.

Related Devices (Code: IPF)

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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