FDA 510(k)

LL TENS 160A, LL TENS 160B

K-Number: K152374 · 2016-01-13

Decision Date2016-01-13

Product CodeNUH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

LL TENS 160A, LL TENS 160B is a medical device manufactured by Fuji Dynamics , Ltd.. It received FDA 510(k) clearance on 2016-01-13 under approval number K152374. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LL TENS 160A, LL TENS 160B?

LL TENS 160A, LL TENS 160B is a medical device that received FDA 510(k) clearance on 2016-01-13. It is manufactured by Fuji Dynamics , Ltd.. The 510(k) number is K152374.

When was LL TENS 160A, LL TENS 160B approved by the FDA?

LL TENS 160A, LL TENS 160B received FDA 510(k) clearance on 2016-01-13, under approval number K152374.

What company makes LL TENS 160A, LL TENS 160B?

LL TENS 160A, LL TENS 160B is manufactured by Fuji Dynamics , Ltd..

What is the FDA product code for LL TENS 160A, LL TENS 160B?

The FDA product code for LL TENS 160A, LL TENS 160B is NUH.

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 K152676FD TENS 2090, FD TENS 2095

Related Devices (Code: NUH)

K162630CP Relief Wand-OTCMid-America Medical Innovations, LLC K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605AWell-Life Healthcare Limited K160508Electronic Pulse StimulatorBeijing Choice Electronic Technololgy Co., Ltd. K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd. K151995Painmaster MCT PatchNewmark, Inc. K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc.

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.