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K Number
K012848
Device Name
WINNER CM4 COMBINATION UNIT
Manufacturer
RICH-MAR CORP.
Date Cleared
2001-10-25

(63 days)

Product Code
GZJ,IPF,LIH
Regulation Number
882.5890
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

THERAPEUTIC ULTRASOUND
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

MICROAMPERAGE PULSED CURRENT INDICATIONS FOR TREATMENT (Microcurrent)
Microcurrent output is indicated for the following conditions:

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

Quadpolar, Bipolar, Monophasic and Russian Waveforms
This device is indicated for the following conditions:

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

(Quadpolar Interferential and Microamperage Pulsed Current)

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

Not Found

AI/ML Overview

This is a 510(k) clearance letter for the Rich-Mar Winner CM4 device, which is a combination of several therapeutic modalities including powered muscle stimulator, TENS, ultrasonic diathermy, ultrasound and muscle stimulator, and interferential current therapy.

The document does not describe a study involving AI or machine learning algorithms, nor does it provide acceptance criteria and performance data in the typical format for such studies. This letter is a regulatory document confirming substantial equivalence to predicate devices, not a performance study report for a novel AI-powered device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truthing, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text. The document pertains to a medical device's regulatory clearance based on its similarity to previously approved devices, not on the performance of an AI component.

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).