(338 days)
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Not Found
No
The summary describes a standard electrical muscle stimulator with no mention of AI or ML capabilities in its intended use, device description, or any other section.
Yes
The device is an "ELECTRICAL MUSCULAR STIMULATOR" with intended uses like "RELAXATION OF MUSCLE SPASM," "PREVENTION OR RETARDATION OF DISUSE ATROPHY," and "INCREASING LOCAL BLOOD CIRCULATION," which are all therapeutic applications.
No
The 'Intended Use / Indications for Use' describe therapeutic applications (e.g., muscle relaxation, re-education, increasing circulation), not the identification or analysis of diseases or conditions. The device is described as an "ELECTRICAL MUSCULAR STIMULATOR," which is a treatment device.
No
The device description explicitly states "SD-970EMS ELECTRICAL MUSCULAR STIMULATOR," indicating a hardware component (the stimulator) is part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The listed indications (muscle relaxation, preventing atrophy, increasing circulation, muscle re-education, preventing venous thrombosis, maintaining range of motion) are all related to physical therapy and rehabilitation, directly affecting the body.
- Device Description: "ELECTRICAL MUSCULAR STIMULATOR" describes a device that applies electrical impulses to muscles, a physical intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions based on in vitro analysis, or any other activity typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function and intended use fall outside of that scope.
N/A
Intended Use / Indications for Use
-
- RELAXATION OF MUSCLE SPASM.
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- PREVENTION OR RETARDATION OF DISUSE ATROPHY.
-
- INCREASING LOCAL BLOOD CIRCULATION.
-
- MUSCLE-RE-EDUCATION.
-
- IMMEDIATE POST SURGICAL STIMULATION OF CALF MUSCLES TO PREVENT VENOUS THROMBOSIS.
-
- MAINTAINING OR INCREASING RANGE OF MOTION.
Product codes
IPF
Device Description
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
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
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. In the center of the seal is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George K.C. Chen President Skylark Device Company Limited Chung Shan North Road 12th Floor, 34, Section 3 Taipei, Taiwan
OCT - 9 1997
Re : K964434 Trade Name: SD-970EMS Electrical Muscular Stimulator Regulatory Class: II Product Code: IPF Dated: July 17, 1997 Received: July 23, 1997
Dear Mr. 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. ਚੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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.
1
Page 2 - Mr. George K.C. Chen
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 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaración Chercica) Hibbidhang by Briadoleres
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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR Device Name:
Indications For Use:
-
- RELAXATION OF MUSCLE SPASM.
-
- PREVENTION OR RETARDATION OF DISUSE ATROPHY.
-
- INCREASING LOCAL BLOOD CIRCULATION.
-
- MUSCLE-RE-EDUCATION.
-
- IMMEDIATE POST SURGICAL STIMULATION OF CALF MUSCLES TO PREVENT VENOUS THROMBOSIS.
-
- MAINTAINING OR INCREASING RANGE OF MOTION.
(F_EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation Prescription Use ૦ત Over-The-Counter Use_ (Per 21 CFR 801.109) (Optional Format 1-2-96)