GrindCare System

FDA 510(k) K163448 · Sunstar Suisse S.A.

Substantially Equivalent

510(k) numberK163448

Submission

Device name
GrindCare System
Applicant
Sunstar Suisse S.A.
Etoy, CH
Received
December 8, 2016
Decision date
September 1, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HCC – Device, Biofeedback
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Specialty
Neurology

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K151050Pacifier Activated Lullaby (PAL®)HCC · Traditional Power Medical Devices, LLC12/22/2015SE
K143507NFANT Feeding SolutionHCC · Traditional Nfant Labs, LLC09/09/2015SE
K131586Canary Breathing SystemHCC · Traditional Palo Alto Health Sciences, Inc.12/10/2013SE
K122879EEGER4 Model 4.3HCC · Traditional Eeg Software, LLC02/06/2013SE
K111687Emg SystemHCC · Special Myotronics-Noromed, Inc.09/29/2011SE
K092675GrindcareHCC · Traditional Medotech A/S03/03/2010SE
K073557EEG Neuroamp, Model CS10137HCC · Traditional Corscience GmbH & Co. KG02/28/2008SE

Questions and answers

When was GrindCare System cleared by the FDA?

GrindCare System (K163448) received a 510(k) decision of Substantially Equivalent on September 1, 2017, 267 days after the submission was received.

What is the product code of K163448?

The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.