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FDA 510(k)

MODEL MK II TENS

K-Number: K833251 · 1984-03-05

ApplicantEuropean Electronic Systems, Ltd.
Decision Date1984-03-05
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL MK II TENS is the device name listed in this FDA 510(k) record. The listed applicant is European Electronic Systems, Ltd.. It received FDA 510(k) clearance on 1984-03-05 under 510(k) number K833251. 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 MODEL MK II TENS?

MODEL MK II TENS is a medical device that received FDA 510(k) clearance on 1984-03-05. The listed applicant is European Electronic Systems, Ltd.. The 510(k) number is K833251.

When did MODEL MK II TENS receive FDA 510(k) clearance?

MODEL MK II TENS received FDA 510(k) clearance on 1984-03-05, under 510(k) number K833251.

Who is the listed applicant for MODEL MK II TENS?

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

What is the FDA product code for MODEL MK II TENS?

The FDA product code for MODEL MK II TENS is GZJ.

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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

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

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