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