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FDA 510(k)

MEDISANA DIGITAL TENS

K-Number: K994265 · 2000-07-06

ApplicantFuji Dynamics Limited
Decision Date2000-07-06
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEDISANA DIGITAL 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 2000-07-06 under 510(k) number K994265. 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 MEDISANA DIGITAL TENS?

MEDISANA DIGITAL TENS is a medical device that received FDA 510(k) clearance on 2000-07-06. The listed applicant is Fuji Dynamics Limited. The 510(k) number is K994265.

When did MEDISANA DIGITAL TENS receive FDA 510(k) clearance?

MEDISANA DIGITAL TENS received FDA 510(k) clearance on 2000-07-06, under 510(k) number K994265.

Who is the listed applicant for MEDISANA DIGITAL 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 MEDISANA DIGITAL TENS?

The FDA product code for MEDISANA DIGITAL TENS is GZJ.

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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-FJ27FK041164L-TENSK994266FDTENS 2010

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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.

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