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FDA 510(k)

TRANSAMERICAN TENS

K-Number: K010782 · 2001-04-27

ApplicantTransamerica Medical Systems
Decision Date2001-04-27
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TRANSAMERICAN TENS is the device name listed in this FDA 510(k) record. The listed applicant is Transamerica Medical Systems. It received FDA 510(k) clearance on 2001-04-27 under 510(k) number K010782. 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 TRANSAMERICAN TENS?

TRANSAMERICAN TENS is a medical device that received FDA 510(k) clearance on 2001-04-27. The listed applicant is Transamerica Medical Systems. The 510(k) number is K010782.

When did TRANSAMERICAN TENS receive FDA 510(k) clearance?

TRANSAMERICAN TENS received FDA 510(k) clearance on 2001-04-27, under 510(k) number K010782.

Who is the listed applicant for TRANSAMERICAN TENS?

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

What is the FDA product code for TRANSAMERICAN TENS?

The FDA product code for TRANSAMERICAN TENS 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 Transamerica Medical Systems 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.

K010665TRANSAMERICA DIGITAL EMSK961749TRANSAMERICA ELECTRODE

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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