(129 days)
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Not Found
No
The summary describes a standard electrical stimulator with no mention of AI/ML features or data processing that would typically involve such technologies.
Yes
The device's intended use explicitly states it is for adjunctive therapy for the treatment of medical diseases and conditions, which is the definition of a therapeutic device.
No
The device's stated indications are for therapeutic purposes (e.g., muscle relaxation, preventing atrophy, muscle re-education), not for identifying or diagnosing a disease or condition.
No
The intended use explicitly states the device applies an electrical current to electrodes on the patient's skin, which requires hardware components (electrodes, power source, circuitry to generate and control the current). This is not a software-only function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes applying electrical current to a patient's skin for therapeutic purposes (muscle relaxation, re-education, etc.). This is a direct interaction with the patient's body for treatment, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility.
- Clinical Settings: The device is used under medical supervision for adjunctive therapy, which aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information.
Therefore, this device falls under the category of a therapeutic medical device, specifically likely an electrical stimulator, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Specific indications: used to apply an electrical current to electrodes on patient's skin to function as: Relaxation of muscle spasms; Prevention or retardation of disuse atrophy Muscle re-education; Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; Maintaining or increasing range of motion.
- Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.
Product codes
IPF
Device Description
SUN-TENS PALM TYPE R5 / COMPACT WIRELESS M2 EMS SERIES
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Under medical supervisions
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of three overlapping human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2001
Sun-Rain System Corporation c/o Mr. Yang Tien-Hising ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City, Taipei, Taiwan ROC
Re: K011913
Trade/Device Name: Sun-Tens Palm Type R5/Compact Wireless M2 EMS Series Regulation Number: 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: September 10, 2001 Received: October 9, 2001
Dear Mr. Tien-Hising:
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 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.
1
Page 2 - Mr. Yang Tien-Hising
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse FDA finding of substantial equivalence of your device to a legally promative notification. The 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 additionally 21 CF 1 F ar 4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-461 the Office of Compliance at (301) 594-4639. 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 Oiner general miormation sturers, 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,
R. Mark N. Millikan
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
2
SUN-RAIN SYSTEM CORP.
F 8, NO. 125, LANE 235, BAO-CHIAO RD., HSIN-TIEN CITY, TAIPEI, TAIWAN R.O.C. E-MAIL:suncorp@ms14.hinet.net TEL: 886-2-8919-1180 WEB: www.sun-rain.com.tw FAX: 886-2-8919-1190
Page 1 of of 1 -
Applicant: __ SUN-RAIN SYSTEM CORPORATION_
510(k) Number ( if known): __________________________________________________________________________________________________________________________________________________
Device Name: SUN-TENS PALM TYPE R5 / COMPACT WIRELESS M2 EMS SERIES
Indications For Use:
- Specific indications: used to apply an electrical current to electrodes on ● patient's skin to function as:
Relaxation of muscle spasms;
Prevention or retardation of disuse atrophy
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion.
- Clinical settings: The device should only be used under medical supervisions ● · for adjunctive therapy for the treatment of medical diseases and conditions.
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, office of Device Evaluation (ODE)
| Mark N Millerson (Division Sign-Off) | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------ |
Division of General, Restorative
and Neurological Devices
| Prescription Use | ✓ |
|---|---|
| ( Per 21 CFR 801.109 ) |
| 510(k) Number | K011913 |
|---|---|
| OR510(k) Number The-Counter-Use | MNM |
| ( Optional Format 1-2-96 ) |