ACU-STIM TENS, AP-101082T by APEX MEDICAL CORP.

INDICATIONS: Transcutaneous Electrical Nerve Stimulator (TENS) devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as adjunctive treatment in the management of post surgical and post traumatic acute pain problems.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for two TENS devices: Multi-Stim TENS (AP-101081T) and Acu-Stim TENS (AP-101082T). This document does not contain information about acceptance criteria or a study proving device performance against such criteria.

The letter explicitly states that the devices are deemed "substantially equivalent" to legally marketed predicate devices. This means that the FDA reviewed documentation demonstrating that the new devices have the same intended use, technological characteristics, and safety and effectiveness as the predicate devices.

Therefore, I cannot provide the requested information based on the given text.

To be clear:

No acceptance criteria are mentioned.
No study proving device performance against acceptance criteria is described.
No information on sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies is present.
No human-in-the-loop performance or standalone algorithm performance is discussed.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 1998

Mr. Daniel Lee President Apex Medical Corporation 10th Floor, Number 31, Lane 169 Kang Ning Street HSI Chih Chen, Taipei Hsien Taiwan R.O.C.

Re: K973979 Multi-Stim TENS, AP-101081T Trade Name: K973980 Acu-Stim TENS, AP-101082T Trade Name: Regulatory Class: II Product Code: GZJ June 2, 1998 Dated: Received: July 2, 1998

Dear Mr. Lee:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with -----the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.

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Page 2 - Mr. Daniel Lee

concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ia M. Witten/ Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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510(k) Number (if known):

ACU-STIM TENS Device Name:

Indications For Use:

CONTRAINDICATIONS: TENS devices can affect the operation of demand type cardiac paccmakers. TENS is not recommended for patients with know heart disease without physical evaluation of possible risk. Do not stimulate over the eyes or carotid sinus nerves. Do not apply TENS for undiagnosed pain syndromes until the etiology is established.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).