APEX MEDICAL LCD TENS-VII

K012643 · Apex Medical Corp. · GZJ · Oct 29, 2001 · Neurology

Device Facts

• Record ID: K012643
• Device Name: APEX MEDICAL LCD TENS-VII
• Applicant: Apex Medical Corp.
• Product Code: GZJ · Neurology
• Decision Date: Oct 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Apex Medical LCD TENS-VII is a transcutaneous electrical nerve stimulator (TENS). Device delivers electrical pulses to patient skin via electrodes to provide symptomatic relief of chronic intractable, post-traumatic, and post-surgical pain. Operated by patient or clinician; device functions as a portable stimulator. Output consists of controlled electrical stimulation parameters (frequency, pulse width, intensity) adjusted by user to manage pain. Benefits include non-pharmacological pain management.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Transcutaneous electrical nerve stimulator (TENS). Device utilizes electrical stimulation for pain management. Form factor is a portable unit with an LCD interface. Operates as a prescription-use device under 21 CFR 882.5890.

Indications for Use

Indicated for symptomatic relief of chronic intractable pain, post-traumatic pain, and post-surgical pain in patients requiring transcutaneous electrical nerve stimulation.

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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Public Health Service

OCT 2 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alan Chang Research and Development Manager Apex Medical Corporation 10th Floor, No. 31, Lane 169 Kang Ning Street His Chih Chen, Taipei Hsien, 221, Taiwan ROC

Re: K012643

Trade/Device Name: Apex Medical LCD TENS-VII Regulation Number: 882.5890 Regulation Name: Transcutaneous electrical stimulator Regulatory Class: II Product Code: GZJ Dated: August 7, 2001 Received: August 13, 2001

Dear Mr. Chang:

We have reviewed your Section 510(k) premarket 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 for associated in 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Alan Chang

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

for Mark N. Mellerson

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 : KO12643 Device Name : Apex Medical LCD TENS-VII

Indications For Use:

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-The-Counter-Use_ OR Prescription Use _ × (Optional Format 1-2-96) (Per 21 CFR 801.109) ನ

510(k) Number ---