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FDA 510(k)

MAGBODY DT-600

K-Number: K053284 · 2006-03-10

ApplicantDurtech System Corp.
Decision Date2006-03-10
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MAGBODY DT-600 is the device name listed in this FDA 510(k) record. The listed applicant is Durtech System Corp.. It received FDA 510(k) clearance on 2006-03-10 under 510(k) number K053284. 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 MAGBODY DT-600?

MAGBODY DT-600 is a medical device that received FDA 510(k) clearance on 2006-03-10. The listed applicant is Durtech System Corp.. The 510(k) number is K053284.

When did MAGBODY DT-600 receive FDA 510(k) clearance?

MAGBODY DT-600 received FDA 510(k) clearance on 2006-03-10, under 510(k) number K053284.

Who is the listed applicant for MAGBODY DT-600?

The FDA 510(k) record lists Durtech System Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGBODY DT-600?

The FDA product code for MAGBODY DT-600 is GZJ.

Related Clinical Trials

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.

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Other records listing Durtech System Corp. 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.

K053285MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM

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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