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FDA 510(k)

NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM

K-Number: K111279 · 2011-09-20

ApplicantZynex Medical, Inc.
Decision Date2011-09-20
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zynex Medical, Inc.. It received FDA 510(k) clearance on 2011-09-20 under 510(k) number K111279. 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 NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM?

NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-20. The listed applicant is Zynex Medical, Inc.. The 510(k) number is K111279.

When did NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM receive FDA 510(k) clearance?

NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM received FDA 510(k) clearance on 2011-09-20, under 510(k) number K111279.

Who is the listed applicant for NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM?

The FDA 510(k) record lists Zynex Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM?

The FDA product code for NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM is IPF.

Related Clinical Trials

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Other records listing Zynex Medical, Inc. 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.

K233485M-WaveK223217Zynex Monitoring System, Model CM-1600K191697Cardiac Monitor 1500K121820INWAVE

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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