MULTI-STIM TENS, AP-101081T

K973979 · Apex Medical Corp. · GZJ · Jul 29, 1998 · Neurology

Device Facts

• Record ID: K973979
• Device Name: MULTI-STIM TENS, AP-101081T
• Applicant: Apex Medical Corp.
• Product Code: GZJ · Neurology
• Decision Date: Jul 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

TENS device delivers electrical stimulation to nerves for pain management. Operates via electrodes placed on patient skin; provides symptomatic relief for chronic intractable pain and adjunctive treatment for acute post-surgical or post-traumatic pain. Used in clinical or home settings; operated by patients or clinicians. Device generates electrical pulses to modulate pain signals. Benefits include non-pharmacological pain management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Transcutaneous Electrical Nerve Stimulator (TENS). Electrical stimulation output. Class II device. Product code GZJ.

Indications for Use

Indicated for symptomatic relief/management of chronic intractable pain and adjunctive treatment of post-surgical/post-traumatic acute pain. Contraindicated for patients with demand-type cardiac pacemakers, known heart disease (without prior evaluation), stimulation over eyes or carotid sinus nerves, and undiagnosed pain syndromes.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 29 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.

K973979 Re: Multi-Stim TENS, AP-101081T Trade Name: K973980 Trade Name: Acu-Stim TENS, AP-101082T Regulatory Class: II Product Code: GZJ Dated: June 2, 1998 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 regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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

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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 requlations.

This letter will allow you to beqin 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 [phone]. Additionally, for questions on the promotion and advertising of your devices, 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

Enclosures

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510(k) Number (if known):

MULTI-STIM TENS Device Name:

Indications For Use:

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.

CONTRAINDICATIONS: TENS devices can affect the operation of demand type cardiac pacemakers. TENS is not recommended for patients with know heart discase 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)

(Division Sign-Off)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K973979

scription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)