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FDA 510(k)

TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM

K-Number: K063728 · 2007-04-04

ApplicantAlfa Tech Medical Systems, Ltd.
Decision Date2007-04-04
Product CodeIMG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Tech Medical Systems, Ltd.. It received FDA 510(k) clearance on 2007-04-04 under 510(k) number K063728. The device is classified under product code IMG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM?

TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-04-04. The listed applicant is Alfa Tech Medical Systems, Ltd.. The 510(k) number is K063728.

When did TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM receive FDA 510(k) clearance?

TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM received FDA 510(k) clearance on 2007-04-04, under 510(k) number K063728.

Who is the listed applicant for TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM?

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

What is the FDA product code for TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM?

The FDA product code for TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM is IMG.

Related Clinical Trials

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Other records listing Alfa Tech Medical Systems, 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.

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Related Devices (Code: IMG)

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.

K244041Ultrasound Therapy Workstation (XMS-UET2)Xemis Medical Technology (Shenzhen) Co., Ltd.K153559OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy SystemAccelerated Care Plus (Acp)K120217SONICSTIMU COMBO THERAPEUTIC DEVICEShenzhen Dongdixin Technology Co., Ltd.K121059SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIMZimmer Medizinsystems GmbHK102524FUTURADr. Oliver Wenker, M.D., M.B.A.K111482SONICATOR PLUS 920Mettler Electronics Corp.

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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