TENSWave— 510(k) K241228

Substantially Equivalent

Zynex Medical Officer

FDA 510(k) clearance K241228 for TENSWave, Substantially Equivalent on 2024-08-27. Applicant: Zynex Medical Officer. Device class: 2.

Clearance details

Applicant: Zynex Medical Officer
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2024-05-02
Decision date: 2024-08-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.