(354 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description is for a standard powered muscle stimulator.
Yes
The device is described as an "adjunctive therapy for the treatment of medical diseases and conditions" which directly relates to therapeutic intent.
No
The device's intended use is to apply an electrical current for muscle relaxation and adjunctive therapy, not to diagnose medical conditions.
No
The device description explicitly states "TAI SHENG Powered Muscle Stimulator, TS-L166," which is a hardware device that applies electrical current. The summary does not indicate it is solely software controlling an existing hardware platform.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply electrical current to the skin for muscle stimulation and relaxation of muscle spasms. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a "Powered Muscle Stimulator." This aligns with a therapeutic device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro methods, or providing diagnostic information.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to directly interact with the patient's body for therapeutic purposes.
N/A
Intended Use / Indications for Use
-
. Specific indications: used to apply an electrical current to electrodes on pation's . skin to function as:
Relaxation of muscle spasms; -
Clinical settings: The device should only be used under medical supervisions for . adjunctive therapy for the treatment of medical discases and conditions.
Product codes
IPF
Device Description
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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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical supervisions
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)
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
APR 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TAI Sheng Electrical Machinery Co., C/o: Dr. Jen, Ke-Min R.O.C. Chinesc-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Rc: K031310
Trade/Device Name: TAI SHENG Powered Muscle Stimulator, TS-L166 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: February 17, 2004 Received: February 25, 2004
Dear Dr. Jen, Ke-Min:
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 - Dr. Jen, Ke-Min
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 (301) 594-4659. 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. McMillan
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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4. INDICATIONS FOR USE STATEMENT
Applicant : 510(k) Number : Device Name: TAI SHENG Powered Muscle Stimulator, TS-L166
Indications for Use :
-
. Specific indications: used to apply an electrical current to electrodes on pation's . skin to function as:
Relaxation of muscle spasms; -
Clinical settings: The device should only be used under medical supervisions for . adjunctive therapy for the treatment of medical discases and conditions.
(PLFASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence Vice Evaluation (ODE) Division of General, Restorative, and Neurological Devices 631310 510(k) Number_ X Prescription Use OR Over-The-Counter Per 21 CFR 801.109 (Optional Format 1-2-96)