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

FDA 510(k)

FD TENS 2090, FD TENS 2095

K-Number: K152676 · 2016-01-22

ApplicantFuji Dynamics , Ltd.
Decision Date2016-01-22
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FD TENS 2090, FD TENS 2095 is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Dynamics , Ltd.. It received FDA 510(k) clearance on 2016-01-22 under 510(k) 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. The listed applicant is Fuji Dynamics , Ltd.. The 510(k) number is K152676.

When did FD TENS 2090, FD TENS 2095 receive FDA 510(k) clearance?

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

Who is the listed applicant for FD TENS 2090, FD TENS 2095?

The FDA 510(k) record lists Fuji Dynamics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Fuji Dynamics , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: GZJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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.

↑