Cleared Abbreviated

TENSWave

K241228 · Zynex Medical Officer · Physical Medicine

Aug 2024

Decision

117d

Days

Class 2

Risk

About This 510(k) Submission

K241228 is an FDA 510(k) clearance for the TENSWave, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Zynex Medical Officer (Englewood, US). The FDA issued a Cleared decision on August 27, 2024, 117 days after receiving the submission on May 2, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K241228 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2024
Decision Date	August 27, 2024
Days to Decision	117 days
Submission Type	Abbreviated
Review Panel	Physical Medicine (PM)
Summary	Statement