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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 a medical device manufactured by Medlander Medical Technology, Inc.. It received FDA 510(k) clearance on 2022-10-21 under approval 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. It is manufactured by Medlander Medical Technology, Inc.. The 510(k) number is K222201.

When was Biological Feedback and Stimulation System approved by the FDA?

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

What company makes Biological Feedback and Stimulation System?

Biological Feedback and Stimulation System is manufactured by Medlander Medical Technology, Inc..

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 Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT03258580 Sociocultural & Biobehavioral Influences on Pain Expression and Assessment RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT04246281 The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain COMPLETED NCT07608614 Sleep and Performance RECRUITING

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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