NORMATEC MVP— 510(k) K112890

Substantially Equivalent

NormaTec Industries, LP

FDA 510(k) clearance K112890 for NORMATEC MVP, Substantially Equivalent on 2012-01-04. Applicant: NormaTec Industries, LP. Device class: 2.

Clearance details

Applicant: NormaTec Industries, LP
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2011-09-30
Decision date: 2012-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.