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)

L-TENS

K-Number: K041164 · 2004-05-20

ApplicantFuji Dynamics Limited
Decision Date2004-05-20
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

L-TENS is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Dynamics Limited. It received FDA 510(k) clearance on 2004-05-20 under 510(k) number K041164. 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 L-TENS?

L-TENS is a medical device that received FDA 510(k) clearance on 2004-05-20. The listed applicant is Fuji Dynamics Limited. The 510(k) number is K041164.

When did L-TENS receive FDA 510(k) clearance?

L-TENS received FDA 510(k) clearance on 2004-05-20, under 510(k) number K041164.

Who is the listed applicant for L-TENS?

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

What is the FDA product code for L-TENS?

The FDA product code for L-TENS is GZJ.

Other records listing Fuji Dynamics Limited 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.

K092780INF 4160 PLUS, MODEL D-FJ31FK063642FD EMS, MODEL # D-FJ30EK052813FD TENS 2030, MODEL DFJ24TK043407INF 4160, MODEL D-FJ27FK994265MEDISANA DIGITAL TENSK994266FDTENS 2010

View all 7 devices →

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.

↑