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510(k) Data Aggregation

K Number

Device Name

TENSWave

Manufacturer

Zynex Medical Officer

Date Cleared

2024-08-27

(117 days)

Product Code

GZJ

Regulation Number

882.5890

Why did this record match?

Applicant Name (Manufacturer) :

Zynex Medical Officer

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The TENSWave is indicated for management and symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.

Device Description

Not Found

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