NormaTec Pulse and NormaTec Pulse Pro— 510(k) K160608

Name: FDA 510(k) clearance K160608
Creator: U.S. Food and Drug Administration
Published: 2016-04-13

Substantially Equivalent

NormaTec Industries, LP

FDA 510(k) clearance K160608 for NormaTec Pulse and NormaTec Pulse Pro, Substantially Equivalent on 2016-04-13. 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: 2016-03-03
Decision date: 2016-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, MA, 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.