SD-970EMS ELECTRICAL MUSCULAR STIMULATOR

• K Number: K964434
• Device Name: SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
• Manufacturer: SKYLARK DEVICE CO., LTD.
• Date Cleared: 1997-10-09 ( 338 days)
• Product Code: IPF
• Regulation Number: 890.5850
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

• 1. RELAXATION OF MUSCLE SPASM.
• 2. PREVENTION OR RETARDATION OF DISUSE ATROPHY.
• 3. INCREASING LOCAL BLOOD CIRCULATION.
• 4. MUSCLE-RE-EDUCATION.
• 5. IMMEDIATE POST SURGICAL STIMULATION OF CALF MUSCLES TO PREVENT VENOUS THROMBOSIS.
• 6. MAINTAINING OR INCREASING RANGE OF MOTION.

Device Description

SD-970EMS ELECTRICAL MUSCULAR STIMULATOR

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the "SD-970EMS Electrical Muscular Stimulator," indicating that the device has been determined to be substantially equivalent to a predicate device.

The letter mentions:

• Trade Name: SD-970EMS Electrical Muscular Stimulator
• Regulatory Class: II
• Product Code: IPF
• 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, and maintaining or increasing range of motion.

It does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study (sample size, data provenance, expert numbers, adjudication methods, MRMC studies, standalone performance, ground truth types).
• Information on training sets or how their ground truth was established.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

Summary

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

SD-970EMS ELECTRICAL MUSCULAR STIMULATOR Device Name:

Indications For Use:

• 1. RELAXATION OF MUSCLE SPASM.
• 2. PREVENTION OR RETARDATION OF DISUSE ATROPHY.
• 3. INCREASING LOCAL BLOOD CIRCULATION.
• 4. MUSCLE-RE-EDUCATION.
• 5. IMMEDIATE POST SURGICAL STIMULATION OF CALF MUSCLES TO PREVENT VENOUS THROMBOSIS.
• 6. 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)

Regulation Number and Section

§ 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).