BiowaveHOME Neuromodulation Pain Therapy Device— 510(k) K152437

Name: FDA 510(k) clearance K152437
Creator: U.S. Food and Drug Administration
Published: 2015-09-25

Substantially Equivalent

Biowave Corporation

FDA 510(k) clearance K152437 for BiowaveHOME Neuromodulation Pain Therapy Device, Substantially Equivalent on 2015-09-25. Applicant: Biowave Corporation. Device class: 2.

Clearance details

Applicant: Biowave Corporation
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2015-08-27
Decision date: 2015-09-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Norwalk, CT, 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.