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FDA 510(k)

STIMPOD NMS460 Nerve Stimulator

K-Number: K161091 · 2017-01-18

ApplicantXavant Technology (Pty), Ltd.
Decision Date2017-01-18
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STIMPOD NMS460 Nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Xavant Technology (Pty), Ltd.. It received FDA 510(k) clearance on 2017-01-18 under 510(k) number K161091. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STIMPOD NMS460 Nerve Stimulator?

STIMPOD NMS460 Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2017-01-18. The listed applicant is Xavant Technology (Pty), Ltd.. The 510(k) number is K161091.

When did STIMPOD NMS460 Nerve Stimulator receive FDA 510(k) clearance?

STIMPOD NMS460 Nerve Stimulator received FDA 510(k) clearance on 2017-01-18, under 510(k) number K161091.

Who is the listed applicant for STIMPOD NMS460 Nerve Stimulator?

The FDA 510(k) record lists Xavant Technology (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STIMPOD NMS460 Nerve Stimulator?

The FDA product code for STIMPOD NMS460 Nerve Stimulator is GZJ.

Other records listing Xavant Technology (Pty), Ltd. 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.

K213049STIMPOD NMS450 Nerve Stimulator

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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