PROVANT SYSTEM, MODEL 4201— 510(k) K091791

Name: FDA 510(k) clearance K091791
Creator: U.S. Food and Drug Administration
Published: 2010-04-07

Substantially Equivalent

Regenesis Biomedical, Inc.

FDA 510(k) clearance K091791 for PROVANT SYSTEM, MODEL 4201, Substantially Equivalent on 2010-04-07. 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: 2009-06-17
Decision date: 2010-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

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