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K Number
K130424

Validate with FDA (Live)

Device Name
STIMEL-03
Manufacturer
STIMEL LTD
Date Cleared
2013-07-11

(141 days)

Product Code
IPF
Regulation Number
890.5850
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The STIMEL-03 is indicated for:

  1. Relaxation of muscle spasms .
  2. Prevention or retardation of disuse atrophy
  3. Increasing local blood circulation
  4. Stroke Rehabilitation by muscle re-education
  5. Maintaining or increasing range of motion.
  6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
    Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) K130424 letter from the FDA regarding the STIMEL-03 device, a powered muscle stimulator. It does not contain information about acceptance criteria, device performance, study design, sample sizes, ground truth establishment, or expert qualifications.

The document details:

  • The FDA's review and determination of substantial equivalence for the STIMEL-03 device.
  • Regulatory information, including classification (Class II), product code (IPF), and applicable regulations.
  • General controls provisions of the Act that the device must comply with.
  • Contact information for various FDA divisions.
  • The Indications for Use for the STIMEL-03 device, which are:
    1. Relaxation of muscle spasms.
    2. Prevention or retardation of disuse atrophy.
    3. Increasing local blood circulation.
    4. Stroke Rehabilitation by muscle re-education.
    5. Maintaining or increasing range of motion.
    6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
  • A note that powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
  • The device is for Prescription Use.

Therefore, I cannot provide the requested information about acceptance criteria and study details based on the provided text. This type of information is typically found in the 510(k) summary or the full submission, not in the FDA's final clearance letter.

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Image /page/0/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.

DEPARTMENT OF HEALTH & HUMAN SERVICES

July 11,2013

Stimel Ltd. % Raymond J. Kelly, IV Arazy Group 57 Lazy Brook Rd. Monroe, CT 06468

Re: K130424

Trade/Device Name: STIMEL-03 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: June 10, 2013 Received: June 12, 2013

Dear Mr. Kelly:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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Page 2 - Mr. Raymond J. Kelly, IV

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/Medica]Devices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K130424

Device Name: STIMEL-03

Indications for Use:

The STIMEL-03 is indicated for:

  1. Relaxation of muscle spasms .

  2. Prevention or retardation of disuse atrophy

  3. Increasing local blood circulation

  4. Stroke Rehabilitation by muscle re-education

  5. Maintaining or increasing range of motion.

  6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jovce M. Whang -

Division Sign Off) ivision of Neurological and Physical Medicine evices (DNPMD)

K130424 510(k) Number

§ 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).