SDS-4I

K034005 · Skylark Device & Systems Co., Ltd. · IPF · Nov 18, 2004 · Physical Medicine

Device Facts

• Record ID: K034005
• Device Name: SDS-4I
• Applicant: Skylark Device & Systems Co., Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Nov 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indication Use For EMS (Code 10, 20-22,30-33_) Only Relax muscle Spasms Prevent or retard disuse atrophy Maintain or increase range of motion Increase local blood circulation Re-educate muscle Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Indication Use For IF (Code 11-18, 20-22,30-33) For symptomatic relief and management of chronic pain and /or as an adjunctive treatment in the management of post -surgical and post-traumatic acute pain. Powered muscle stimulators should only be used under medical supervision

Device Story

SDS-4I is a powered muscle and interferential current stimulator. Device inputs include user-selected stimulation parameters; outputs are electrical pulses delivered via electrode pads. Operates in two modalities: muscle stimulation (symmetrical bi-phasic pulses, 23V/46mA max, 75Hz) and interferential current (sine wave symmetric, 80mA max). Interferential mode supports 4-pad true interferential or 2-pad pre-mixed signals. Device features plastic enclosure with character LCD display. Used under medical supervision in clinical settings. Healthcare providers use output to manage pain, muscle spasms, and atrophy. Benefits include improved circulation, muscle re-education, and pain management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Plastic enclosure; character LCD display. Modalities: muscle stimulation (symmetrical bi-phasic, 23V/46mA, 75Hz) and interferential current (sine wave symmetric, 80mA). 2-pad or 4-pad configuration. Powered by AC charging adapter. No software algorithm class specified.

Indications for Use

Indicated for patients requiring muscle stimulation to relax spasms, prevent disuse atrophy, maintain/increase range of motion, increase local blood circulation, re-educate muscle, or prevent venous thrombosis post-surgery. Also indicated for symptomatic relief of chronic pain and adjunctive treatment of post-surgical/post-traumatic acute pain. Must be used under medical supervision.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• EMS400 (K912642)
• IF-SD730 (K992652)
• RS-4i (K032652)

Submission Summary (Full Text)

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# 510(k) SUMMARY

K034005

#### NOV 1 8 2004 SDS-4I

This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k), premarket notification was in accordance with 21 CFR 807.87.

# 1. Applicant, Official Correspondent and Owner of 510(k)

Skylark Device& Systems Co., Ltd. 4F 34 Sec3 Chung Shan N. Road Taipei, Taiwan Attn: George Chiang, Ph.D. Tel: [phone] ext301 Fax: [phone]

### 2. Name of Device

Trade/ Propriety Name: SDS-4I Common/ Usual Name: Muscular and Interferential Current Stimulator Classification name: 21 CFR 890.5850 " Powered Muscle stimulator" Class II.

## 3. Legally Market Predicate Devices

The SDS-41 is substantially equivalent to its legally marketed predecessor the EMS400 (K912642) IF- SD730 (K992652) and RS-4i (K032652)

### 4. Indications for Use:

Indication Use For EMS (Code 10, 20-22,30-33_)

Only Relax muscle Spasms Prevent or retard disuse atrophy Maintain or increase range of motion Increase local blood circulation Re-educate muscle Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

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# Indication Use For IF (Code 11-18, 20-22,30-33)

For symptomatic relief and management of chronic pain and /or as an adjunctive treatment in the management of post -surgical and post-traumatic acute pain.

Powered muscle stimulators should only be used under medical supervision

# 5. Device Description and Substantial Equivalence

The SDS-41 like a number of legally marketed predicate devices incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. The SDS-41 is housed in a plastic enclosure. The front of the enclosure house character LCD display. The accessories provided with the SDS-41 include the output cable, the electrode pads, and the AC Charging Adapter.

The SDS-4I muscle stimulation modality operates at a specified 23 volts max (into a 500 ohm load) and 46mA max (into a 500 ohm load) with a pulse width of 520us Max and a cycle frequency of 75 Hz (±5%). The pulse is Symmetrical bi-phasic. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting.

The SDS-4I interferential modality operates at a specified 80 mA max (into a 500 ohm load). The carrier and interferential signals are sine wave symmetric, balanced outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference Signal frequency can be fixed (continuous) or carried based on three selections (variable).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2004

George Chiang, Ph.D. President Skylark Device & Systems Co., Ltd. 4F. 34 Sec 1 Chung Shan N. Rd. TaiPei, 100 China (Taiwan)

Re: K034005

Trade/Device Name: SDS-4I Regulation Number: 21 CFR 890.5850 and Unclassified Regulation Name: Powered muscle stimulator and Interferential Current stimulator Regulatory Class: II Product Code: IPF,LIH Dated: October 8, 2004 Received: October 12, 2004

Dear Dr. Chiang:

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 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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## Page 2 - Dr. George Chiang

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.

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Mark A. Millerson

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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## Indications for Use

510(k) Number (if known): K034005

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indication Use for EMS (Code 10, 20-22,30-33 )

Only Relax muscle Spasms Prevent or retard disuse atrophy Maintain or increase range of motion Increase local blood circulation Re-educate muscle Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Indication Use for IF (Code 11-18, 20-22, 30-33) For symptomatic relief and management of chronic pain and /or as an adjunctive treatment in the management of post -surgical and post-traumatic acute pain.

Powered muscle stimulators should only be used under medical supervision.

Prescription Use X Over-The-Counter Use _ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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*(Posted November 13, 2003)*

Division of General, Restorative, and Neurological Devices

**510(k) Number** K034005