Normatec Go

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 Go.

Pre-market Notification Details

Device IDK221666
510k NumberK221666
Device Name:Normatec Go
ClassificationMassager, Powered Inflatable Tube
Applicant NormaTec Industries, LP 480 Pleasant Street, Suite A200 Watertown,  MA  02472
ContactSteve Henderson
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIRP  
CFR Regulation Number890.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2022-06-08
Decision Date2022-07-14

Trademark Results [Normatec Go]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NORMATEC GO
NORMATEC GO
90086333 not registered Live/Pending
NormaTec Industries, LP
2020-07-31

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