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FDA 510(k)

Nerve and Muscle Stimulator

K-Number: K211094 · 2021-07-08

ApplicantShenzhen Xft Medical Limited
Decision Date2021-07-08
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Nerve and Muscle Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Xft Medical Limited. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K211094. 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 Nerve and Muscle Stimulator?

Nerve and Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Shenzhen Xft Medical Limited. The 510(k) number is K211094.

When did Nerve and Muscle Stimulator receive FDA 510(k) clearance?

Nerve and Muscle Stimulator received FDA 510(k) clearance on 2021-07-08, under 510(k) number K211094.

Who is the listed applicant for Nerve and Muscle Stimulator?

The FDA 510(k) record lists Shenzhen Xft Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nerve and Muscle Stimulator?

The FDA product code for Nerve and Muscle Stimulator is IPF.

Other records listing Shenzhen Xft Medical Limited 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.

K193276Nerve and Muscle StimulatorK193275Nerve and Muscle StimulatorK162718Foot Drop System (Model XFT-2001D)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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