SD-730 IF-SDS, PERFECT PULSE IF-SDS

K992652 · Skylark Device & Systems Co., Ltd. · LIH · Feb 3, 2000 · Neurology

Device Facts

• Record ID: K992652
• Device Name: SD-730 IF-SDS, PERFECT PULSE IF-SDS
• Applicant: Skylark Device & Systems Co., Ltd.
• Product Code: LIH · Neurology
• Decision Date: Feb 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1.Symptomatic relief of chronic, intractable pain 2.Management of pain associated with post-traumatic or post-operative conditions

Device Story

The SD-730 IF-SDS (Perfect Pulse IF-SDS) is a transcutaneous electrical nerve stimulation (TENS) or similar electrotherapy device used for pain management. It delivers electrical pulses to the body to provide symptomatic relief for chronic, intractable pain and pain related to post-traumatic or post-operative conditions. The device is intended for prescription use. It functions by applying electrical stimulation to the patient, which is a standard modality for pain modulation. The device is operated by the patient or a healthcare provider in a clinical or home setting to alleviate pain symptoms.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

The device is an electrical stimulator for pain management. It operates via electrical pulse delivery. Specific materials, dimensions, and software architecture details are not provided in the document.

Indications for Use

Indicated for patients requiring symptomatic relief of chronic, intractable pain or management of pain associated with post-traumatic or post-operative conditions.

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

FEB 3 2000

George K.C. Chen, Ph.D., M.D. Skylark Device & Systems Co., Ltd. 34 Chung Shan North Road 12th Floor, Section 3 Taipei, Taiwan China

K992652 Re:

Trade Name: SD-730 IF-SDS, Perfect Pulse IF-SDS Regulatory Class: Unclassified Product Code: LIH Dated: Undated Received: November 12, 1999

Dear Dr. Chen:

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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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.

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

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Page 2 - George K.C. Chen, Ph.D., M.D.

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,

Sincerely yours,

Mark N Milkeess

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN): K 992652 DEVICE NAME: SD-730 IF-SDS

INDICATIONS FOR USE:

1.Symptomatic relief of chronic, intractable pain

2.Management of pain associated with post-traumatic or post-operative conditions

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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices

| 510(k) Number | K992652 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div style="display:inline-block;">X</div> | OR | Over-The-Counter-Use (Optional Format 1-2-96) |
|----------------------|--------------------------------------------|----|-----------------------------------------------|
| (Per 21 CFR 801.109) | | | |