PROVANT THERAPY SYSTEM— 510(k) K131979

Name: FDA 510(k) clearance K131979
Creator: U.S. Food and Drug Administration
Published: 2013-12-13

Substantially Equivalent

Regenesis Biomedical, Inc.

FDA 510(k) clearance K131979 for PROVANT THERAPY SYSTEM, Substantially Equivalent on 2013-12-13. Applicant: Regenesis Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Regenesis Biomedical, Inc.
Product code: Code ILX
Device class: Class 2
Regulation: 21 CFR 890.5290
Advisory panel: Physical Medicine
Date received: 2013-06-28
Decision date: 2013-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

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