APEX MEDICAL MINI TENS

K020032 · Apex Medical Corp. · GZJ · Jan 31, 2002 · Neurology

Device Facts

• Record ID: K020032
• Device Name: APEX MEDICAL MINI TENS
• Applicant: Apex Medical Corp.
• Product Code: GZJ · Neurology
• Decision Date: Jan 31, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Mini TENS is intended to be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.

Device Story

Apex Medical Mini TENS is a transcutaneous electrical nerve stimulator used for pain management. Device delivers electrical impulses to nerves via skin electrodes to provide symptomatic relief for chronic intractable, post-traumatic, and post-surgical pain. Operated by patients or clinicians in clinical or home settings. Device functions as a standard TENS unit; provides non-invasive pain modulation. Healthcare providers use output to manage patient pain levels; potential benefit includes reduction in pain perception and improved patient comfort.

Clinical Evidence

No clinical data provided; device relies on established technological characteristics and intended use for TENS therapy.

Technological Characteristics

Transcutaneous Electrical Nerve Stimulator (TENS). Class II device (21 CFR 882.5890). Electrical stimulation via skin electrodes. Portable form factor. No software or complex algorithms described.

Indications for Use

Indicated for symptomatic relief of chronic intractable pain, post-traumatic pain, and post-surgical pain in patients requiring TENS therapy.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2002

Alan Chang Apex Medical Corp. 10th Floor, No. 31 Lane 169 Kang-Ning St. Shi-Chih, Taipei Hsien, Taiwan, R.O.C.

Re: K020032

Trade/Device Name: Apex Medical Mini TENS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ Dated: January 2, 2002 Received: January 4, 2002

Dear Mr. Chang:

We have reviewed your Scetion 510(k) promarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 – Mr. Alan Chang

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
led the election and consection (21 CER Part 820); and if applicable, the electroni CFR Part 807); labeling (21 CFR Part 801); good manufacturing pricable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if annolicable, 105 forth in the quality systems (QS) regulation (21 CFR Part 25) 213-111 (1)
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k)
The status and consember of a lies of a betertial aquivalence of your device to This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The FDA Imaling of substantial equivalence or your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your device directions on the entired to Office of
additionally 21 CFR Part 809.10 for in the securities on the resemblion and advertising additionally 21 CFR Part 809.10 ID III Yuu utenover do noon) promotion and advertising of
Compliance at [phone]. Additionally, for questions on the promotion and adve Compliance at [phone]. Additions of Compliance at (301) S94-4639. Also, please note the your device, please confact the Office of Complants an (or) of including (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarkst notification's be regulation entitled, "Misbranding by reference or promoter the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number Division of Siman Manarace, 16197 or at its Internet address [phone] 01 [phone] 0857 085 http://www.fda.gov/cdrh/dsmamain.html

Sincerely yours,

Mark N Milken

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

Enclosure

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510(k) Number : 长ዕ೭૦૦૩ટ Device Name : Apex Medical Mini TENS Indications For Use:

Mini TENS is intended to be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR

Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)

fo Ma. N. Millison

f General. Restorative and Neurological Decices

510(k) Number_