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FDA 510(k)

THE EMD TENZ PAIN CONTROL SYSTEM

K-Number: K822841 · 1982-11-16

ApplicantElectro Medical Development
Decision Date1982-11-16
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

THE EMD TENZ PAIN CONTROL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Electro Medical Development. It received FDA 510(k) clearance on 1982-11-16 under 510(k) number K822841. 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 THE EMD TENZ PAIN CONTROL SYSTEM?

THE EMD TENZ PAIN CONTROL SYSTEM is a medical device that received FDA 510(k) clearance on 1982-11-16. The listed applicant is Electro Medical Development. The 510(k) number is K822841.

When did THE EMD TENZ PAIN CONTROL SYSTEM receive FDA 510(k) clearance?

THE EMD TENZ PAIN CONTROL SYSTEM received FDA 510(k) clearance on 1982-11-16, under 510(k) number K822841.

Who is the listed applicant for THE EMD TENZ PAIN CONTROL SYSTEM?

The FDA 510(k) record lists Electro Medical Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE EMD TENZ PAIN CONTROL SYSTEM?

The FDA product code for THE EMD TENZ PAIN CONTROL SYSTEM 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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