Pulse 2.0, Pulse Pro 2.0— 510(k) K183169

Name: FDA 510(k) clearance K183169
Creator: U.S. Food and Drug Administration
Published: 2018-12-27

Substantially Equivalent

NormaTec Industries, LP

FDA 510(k) clearance K183169 for Pulse 2.0, Pulse Pro 2.0, Substantially Equivalent on 2018-12-27. 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: 2018-11-16
Decision date: 2018-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

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