Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SimulCare II(TM)

K-Number: K160246 · 2016-10-06

ApplicantXanacare Technologies, LLC
Decision Date2016-10-06
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SimulCare II(TM) is a medical device manufactured by Xanacare Technologies, LLC. It received FDA 510(k) clearance on 2016-10-06 under approval number K160246. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SimulCare II(TM)?

SimulCare II(TM) is a medical device that received FDA 510(k) clearance on 2016-10-06. It is manufactured by Xanacare Technologies, LLC. The 510(k) number is K160246.

When was SimulCare II(TM) approved by the FDA?

SimulCare II(TM) received FDA 510(k) clearance on 2016-10-06, under approval number K160246.

What company makes SimulCare II(TM)?

SimulCare II(TM) is manufactured by Xanacare Technologies, LLC.

What is the FDA product code for SimulCare II(TM)?

The FDA product code for SimulCare II(TM) is GZJ.

Related Devices (Code: GZJ)

K153704StriveDjo, LLC K152676FD TENS 2090, FD TENS 2095Fuji Dynamics , Ltd. K173233ReliefBand 1.5Reliefband Technologies K161091STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. K162663WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605AWell-Life Healthcare Limited K180943BioWaveGOBiowave Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑