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FDA 510(k)

STIMPOD NMS450 Nerve Stimulator

K-Number: K213049 · 2022-10-16

Decision Date2022-10-16
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STIMPOD NMS450 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 2022-10-16 under 510(k) number K213049. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STIMPOD NMS450 Nerve Stimulator?

STIMPOD NMS450 Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2022-10-16. The listed applicant is Xavant Technology (Pty), Ltd.. The 510(k) number is K213049.

When did STIMPOD NMS450 Nerve Stimulator receive FDA 510(k) clearance?

STIMPOD NMS450 Nerve Stimulator received FDA 510(k) clearance on 2022-10-16, under 510(k) number K213049.

Who is the listed applicant for STIMPOD NMS450 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 NMS450 Nerve Stimulator?

The FDA product code for STIMPOD NMS450 Nerve Stimulator is BXN.

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.

Related Devices (Code: BXN)

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.

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.