NormaTec Pulse And NormaTec Pulse Pro

Massager, Powered Inflatable Tube

NORMATEC INDUSTRIES, LP

The following data is part of a premarket notification filed by Normatec Industries, Lp with the FDA for Normatec Pulse And Normatec Pulse Pro.

Pre-market Notification Details

• Device ID: K160608
• 510k Number: K160608
• Device Name: NormaTec Pulse And NormaTec Pulse Pro
• Classification: Massager, Powered Inflatable Tube
• Applicant: NORMATEC INDUSTRIES, LP 44 GLEN AVE Newton, MA 02459
• Contact: Peter Novello
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: IRP
• CFR Regulation Number: 890.5650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2016-03-03
• Decision Date: 2016-04-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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