MICRO II MICROCURRENT TENS

• K Number: K973978
• Device Name: MICRO II MICROCURRENT TENS
• Manufacturer: APEX MEDICAL CORP.
• Date Cleared: 1998-07-29 ( 282 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

This device is restricted to sale or use by or on the order of a physician licensed in the state in which he or she is practicing. It is to be used solely for the symptomatic relief of chronic intractable pain.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a medical device called "MICRO-II MICROCURRENT TENS." This type of document is a regulatory approval, not a scientific study report. It states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, this document does not contain the information requested regarding:

• Acceptance criteria and reported device performance.
• Details of a study proving the device meets acceptance criteria.
• Sample sizes, data provenance, number/qualifications of experts, adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used or how it was established for training or testing.
• Training set sample size.

The document's purpose is to grant market clearance based on substantial equivalence, implying that the device performs similarly to existing, approved devices, rather than presenting novel performance data from a new study against explicit acceptance criteria.

Summary

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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: K973978 Micro II Microcurrent TENS Trade Name: Requlatory Class: II Product Code: GZJ Dated: June 2, 1998 Received: June 4, 1998

Dear Mr. Lee:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, 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 Requlation (QS) for Medical Devices: General regulation (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 action. In addition, FDA may publish further announcements concerning your device 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.

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Page 2 - Mr. Daniel Lee

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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Indications for Use

510(k) Number (if know) :

Device Name : MICRO-II MICROCURRENT TENS

Indications for Use :

INDICATIONS : -

This device is restricted to sale or use by or on the order of a physician licensed in the state in which he or she is practicing. It is to be used solely for the symptomatic relief of chronic intractable pain.

CONTRAINDICATIONS :

• 1.TENS electrodes must be placed in such a position so as to pass electrical current into the carotid gland area.
• 2.TENS must not be prescribed to patients who are using a demand type cardic pacemaker.
• 3. TENS electrodes must not be placed so as to pass current transcerebrally through the head.
• 4.TENS application must not be recommended before pain syndromes are diagnosed,and not before an appropriate etiology has been established.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concuurence of CDRH,Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-26)

(Optional Format 1-26)

IV

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).