TENSWave
K-Number: K241228 · 2024-08-27
ApplicantZynex Medical Officer
Decision Date2024-08-27
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
TENSWave is a medical device manufactured by Zynex Medical Officer. It received FDA 510(k) clearance on 2024-08-27 under approval number K241228. 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 TENSWave?
TENSWave is a medical device that received FDA 510(k) clearance on 2024-08-27. It is manufactured by Zynex Medical Officer. The 510(k) number is K241228.
When was TENSWave approved by the FDA?
TENSWave received FDA 510(k) clearance on 2024-08-27, under approval number K241228.
What company makes TENSWave?
TENSWave is manufactured by Zynex Medical Officer.
What is the FDA product code for TENSWave?
The FDA product code for TENSWave is GZJ.
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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.