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510(k) K241228

TENSWave by Zynex Medical Officer — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2024
Date Received
May 2, 2024
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

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