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FDA 510(k)

CYCLOTEC AMT CTI TENS DEVICE

K-Number: K010615 · 2001-10-12

ApplicantCyclotec
Decision Date2001-10-12
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CYCLOTEC AMT CTI TENS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Cyclotec. It received FDA 510(k) clearance on 2001-10-12 under 510(k) number K010615. 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 CYCLOTEC AMT CTI TENS DEVICE?

CYCLOTEC AMT CTI TENS DEVICE is a medical device that received FDA 510(k) clearance on 2001-10-12. The listed applicant is Cyclotec. The 510(k) number is K010615.

When did CYCLOTEC AMT CTI TENS DEVICE receive FDA 510(k) clearance?

CYCLOTEC AMT CTI TENS DEVICE received FDA 510(k) clearance on 2001-10-12, under 510(k) number K010615.

Who is the listed applicant for CYCLOTEC AMT CTI TENS DEVICE?

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

What is the FDA product code for CYCLOTEC AMT CTI TENS DEVICE?

The FDA product code for CYCLOTEC AMT CTI TENS DEVICE 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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