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FDA 510(k)

CYCLOPAC CP100 TENS BANDAGE

K-Number: K800576 · 1980-05-23

ApplicantCyclotechnical Medical Indust., Inc.
Decision Date1980-05-23
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CYCLOPAC CP100 TENS BANDAGE is the device name listed in this FDA 510(k) record. The listed applicant is Cyclotechnical Medical Indust., Inc.. It received FDA 510(k) clearance on 1980-05-23 under 510(k) number K800576. 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 CYCLOPAC CP100 TENS BANDAGE?

CYCLOPAC CP100 TENS BANDAGE is a medical device that received FDA 510(k) clearance on 1980-05-23. The listed applicant is Cyclotechnical Medical Indust., Inc.. The 510(k) number is K800576.

When did CYCLOPAC CP100 TENS BANDAGE receive FDA 510(k) clearance?

CYCLOPAC CP100 TENS BANDAGE received FDA 510(k) clearance on 1980-05-23, under 510(k) number K800576.

Who is the listed applicant for CYCLOPAC CP100 TENS BANDAGE?

The FDA 510(k) record lists Cyclotechnical Medical Indust., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYCLOPAC CP100 TENS BANDAGE?

The FDA product code for CYCLOPAC CP100 TENS BANDAGE 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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