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FDA 510(k)

TELIGEN System Peripheral Motor Nerve Stimulation Indications

K-Number: K223438 · 2023-02-10

ApplicantMedos International SARL
Decision Date2023-02-10
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TELIGEN System Peripheral Motor Nerve Stimulation Indications is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2023-02-10 under approval number K223438. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELIGEN System Peripheral Motor Nerve Stimulation Indications?

TELIGEN System Peripheral Motor Nerve Stimulation Indications is a medical device that received FDA 510(k) clearance on 2023-02-10. It is manufactured by Medos International SARL. The 510(k) number is K223438.

When was TELIGEN System Peripheral Motor Nerve Stimulation Indications approved by the FDA?

TELIGEN System Peripheral Motor Nerve Stimulation Indications received FDA 510(k) clearance on 2023-02-10, under approval number K223438.

What company makes TELIGEN System Peripheral Motor Nerve Stimulation Indications?

TELIGEN System Peripheral Motor Nerve Stimulation Indications is manufactured by Medos International SARL.

What is the FDA product code for TELIGEN System Peripheral Motor Nerve Stimulation Indications?

The FDA product code for TELIGEN System Peripheral Motor Nerve Stimulation Indications is PDQ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025) PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

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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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