IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II— 510(k) K070541

Name: FDA 510(k) clearance K070541
Creator: U.S. Food and Drug Administration
Published: 2008-12-11

Substantially Equivalent

Ivivi Technologies, Inc.

FDA 510(k) clearance K070541 for IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II, Substantially Equivalent on 2008-12-11. Applicant: Ivivi Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Ivivi Technologies, Inc.
Product code: Code ILX
Device class: Class 2
Regulation: 21 CFR 890.5290
Advisory panel: Physical Medicine
Date received: 2007-02-26
Decision date: 2008-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northvale, NJ, US

Download summary PDF View on FDA.gov ↗

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