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FDA 510(k)

TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001

K-Number: K042107 · 2005-03-09

ApplicantTung FU Electric Co., Ltd.
Decision Date2005-03-09
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001 is the device name listed in this FDA 510(k) record. The listed applicant is Tung FU Electric Co., Ltd.. It received FDA 510(k) clearance on 2005-03-09 under 510(k) number K042107. 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 TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001?

TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001 is a medical device that received FDA 510(k) clearance on 2005-03-09. The listed applicant is Tung FU Electric Co., Ltd.. The 510(k) number is K042107.

When did TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001 receive FDA 510(k) clearance?

TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001 received FDA 510(k) clearance on 2005-03-09, under 510(k) number K042107.

Who is the listed applicant for TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001?

The FDA 510(k) record lists Tung FU Electric Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001?

The FDA product code for TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001 is GZJ.

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Other records listing Tung FU Electric Co., Ltd. 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.

K061452TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM

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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