FDA 510(k)

FD TENS 2090, FD TENS 2095

K-Number: K152676 · 2016-01-22

Decision Date2016-01-22

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

FD TENS 2090, FD TENS 2095 is a medical device manufactured by Fuji Dynamics , Ltd.. It received FDA 510(k) clearance on 2016-01-22 under approval number K152676. 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 FD TENS 2090, FD TENS 2095?

FD TENS 2090, FD TENS 2095 is a medical device that received FDA 510(k) clearance on 2016-01-22. It is manufactured by Fuji Dynamics , Ltd.. The 510(k) number is K152676.

When was FD TENS 2090, FD TENS 2095 approved by the FDA?

FD TENS 2090, FD TENS 2095 received FDA 510(k) clearance on 2016-01-22, under approval number K152676.

What company makes FD TENS 2090, FD TENS 2095?

FD TENS 2090, FD TENS 2095 is manufactured by Fuji Dynamics , Ltd..

What is the FDA product code for FD TENS 2090, FD TENS 2095?

The FDA product code for FD TENS 2090, FD TENS 2095 is GZJ.

Other Devices by Fuji Dynamics , Ltd.

K161055Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 K152374LL TENS 160A, LL TENS 160B

Related Devices (Code: GZJ)

K160246SimulCare II(TM)Xanacare Technologies, LLC K153704StriveDjo, LLC 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

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