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K Number
K130424
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.

§ 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).