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TNN-DU810 Non-Invasive Subdermal Therapy System

by Alfa Tech Medical Systems, Ltd.

510(k) K063728

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063728 Date4 Apr 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IMG
Device Class
Class II
Regulation
21 CFR Part 890.5860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The TNN-DU810 Non-Invasive Subdermal Therapy System is a stimulator, ultrasound and muscle device for use in applying therapeutic deep heat. It is classified under product code IMG and regulation number 890.5860, with a device class of II and medical specialty description in Physical Medicine.

The system is supplied as a non-sterile, reusable device intended for use in clinical settings. It includes a system console with software and control electrodes, and a control and display panel. Authorizations include FDA 510(k) clearance K063728, granted on April 4, 2007, as substantially equivalent to a predicate device.

Other devices from Alfa Tech Medical Systems, Ltd.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the TNN-DU810 Non-Invasive Subdermal Therapy System used for?

    The TNN-DU810 Non-Invasive Subdermal Therapy System is used for applying therapeutic deep heat through stimulation, ultrasound, and muscle therapy. It is intended for use in clinical settings as a non-invasive device to deliver deep heat treatment.

  • Is the TNN-DU810 system sterile or non-sterile, and is it reusable or single-use?

    The TNN-DU810 system is supplied as a non-sterile, reusable device. It is designed for repeated use in clinical environments after appropriate cleaning and maintenance, not for single-use applications.

  • What components are included with the TNN-DU810 Non-Invasive Subdermal Therapy System?

    The system includes a system console with software and control electrodes, along with a control and display panel. These components work together to deliver therapeutic deep heat via stimulation, ultrasound, and muscle modulation.

  • What regulatory clearance does the TNN-DU810 have and when was it granted?

    The TNN-DU810 has FDA 510(k) clearance under number K063728, which was granted on April 4, 2007. It was determined to be substantially equivalent to a predicate device through a traditional 510(k) submission.