MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE

• K Number: K013771
• Device Name: MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
• Manufacturer: RICH-MAR CORP.
• Date Cleared: 2002-01-18 ( 66 days)
• Product Code: IPF , GZJ , IMG , IMI , LIH
• Regulation Number: 890.5850
• Type: Special
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms:

1. Relaxation of muscle spasms.
2. Prevention or retardation of disuse atrophy.
3. Increasing local blood circulation.
4. Muscle re-education.
5. Maintaining or increasing range of motion.
6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms:

1. Symptomatic relief of chronic intractable pain.
2. Management of pain associated with post-traumatic or post operative conditions.

Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:

1. Relief of pain
2. Muscle spasms
3. Joint contractures
   But NOT for the treatment of malignancies

Device Description

Not Found

AI/ML Overview

This document is a 510(k) substantial equivalence determination letter from the FDA for a medical device called the "Rich-Mar Winner CM-2". It does not contain information about acceptance criteria, device performance, or details of a study with sample sizes, expert qualifications, or ground truth establishment.

Here's why the requested information cannot be found in the provided text:

• Nature of the Document: This letter is an FDA approval (or clearance) document, indicating that the device has been deemed "substantially equivalent" to predicate devices already on the market. It confirms that the device can be legally marketed. It is not a report detailing the results of clinical trials, performance studies, or validation efforts.
• Focus on Equivalence: The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove absolute efficacy or performance against a set of predefined acceptance criteria through a specific study. While manufacturers perform testing to support their claims, the FDA letter itself doesn't typically provide those detailed results.
• Missing Sections: The document lacks sections such as "Study Design," "Methods," "Results," "Performance Metrics," or "Clinical Data," which would be present in a study report.

Therefore, I cannot extract the requested information (table of acceptance criteria, device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, types of ground truth, training set size, or ground truth establishment for the training set) from this document.

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).