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FDA 510(k)

geko(TM) Plus R-2 Neuromuscular Stimulator

K-Number: K160299 · 2016-04-08

ApplicantFirstkind Limited
Decision Date2016-04-08
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

geko(TM) Plus R-2 Neuromuscular Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Firstkind Limited. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K160299. 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 geko(TM) Plus R-2 Neuromuscular Stimulator?

geko(TM) Plus R-2 Neuromuscular Stimulator is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Firstkind Limited. The 510(k) number is K160299.

When did geko(TM) Plus R-2 Neuromuscular Stimulator receive FDA 510(k) clearance?

geko(TM) Plus R-2 Neuromuscular Stimulator received FDA 510(k) clearance on 2016-04-08, under 510(k) number K160299.

Who is the listed applicant for geko(TM) Plus R-2 Neuromuscular Stimulator?

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

What is the FDA product code for geko(TM) Plus R-2 Neuromuscular Stimulator?

The FDA product code for geko(TM) Plus R-2 Neuromuscular Stimulator is IPF.

Other records listing Firstkind 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.

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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

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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