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FDA 510(k)

M-Wave

K-Number: K233485 · 2024-01-26

ApplicantZynex Medical, Inc.
Decision Date2024-01-26
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

M-Wave is a medical device manufactured by Zynex Medical, Inc.. It received FDA 510(k) clearance on 2024-01-26 under approval number K233485. 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 M-Wave?

M-Wave is a medical device that received FDA 510(k) clearance on 2024-01-26. It is manufactured by Zynex Medical, Inc.. The 510(k) number is K233485.

When was M-Wave approved by the FDA?

M-Wave received FDA 510(k) clearance on 2024-01-26, under approval number K233485.

What company makes M-Wave?

M-Wave is manufactured by Zynex Medical, Inc..

What is the FDA product code for M-Wave?

The FDA product code for M-Wave is IPF.

Other Devices by Zynex Medical, Inc.

K191697Cardiac Monitor 1500 K223217Zynex Monitoring System, Model CM-1600

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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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