(330 days)
Not Found
No
The device description focuses on traditional electrical stimulation modalities and hardware specifications, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes.
The "Intended Use / Indications for Use" section lists several therapeutic indications, such as "Relax muscle Spasms," "Prevent or retard disuse atrophy," "Increase local blood circulation," and "For symptomatic relief and management of chronic pain." The device also operates under medical supervision.
No
Explanation: The device description and intended use indicate that this device is a muscle stimulator used for therapeutic purposes (e.g., pain relief, muscle re-education, preventing atrophy) rather than for diagnosing medical conditions.
No
The device description explicitly states it is housed in a plastic enclosure and includes physical components like an LCD display, output cable, electrode pads, and an AC Charging Adapter, indicating it is a hardware device with embedded software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to therapeutic applications involving electrical stimulation of muscles and nerves for pain relief, muscle rehabilitation, and preventing conditions like disuse atrophy and venous thrombosis. These are direct treatments applied to the patient's body.
- Device Description: The device description details the electrical stimulation modalities (EMS and IF) and their technical specifications (voltage, current, pulse width, frequency, waveform). This aligns with a therapeutic device that delivers energy to the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition. IVDs are specifically designed for in vitro examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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
Product codes
IPF,LIH
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under medical supervision.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
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: 886-33587677 ext301 Fax: 886-33550731
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
1
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).
2
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
3
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
4
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)
Page _ 1 of /
(Posted November 13, 2003)
Division of General, Restorative, and Neurological Devices
510(k) Number K034005