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K Number
K984142
Device Name
SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994
Manufacturer
METTLER ELECTRONICS CORP.
Date Cleared
1999-02-09

(83 days)

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

Therapeutic Ultrasound: 1. Pain relief 2. Reduction of muscle spasm 3. Localized increase in blood flow 4. Increase range of motion of contracted joints using heat and stretch techniques. Neuromuscular Stimulation: I. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential, Premodulated and Microcurrent waveforms) 2. Temporary relaxation of muscle spasm, (all waveforms except Microcurrent) 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles, (all waveforms except Microcurrent) 4. Increase of blood flow in the treatment area, (all waveforms except Microcurrent) 5. Prevention or retardation of disuse atrophy in post-injury type conditions. (all waveforms except Microcurrent) 6. Muscle re-education, (all waveforms except Microcurrent) 7. Maintaining or increasing range of motion, (all waveforms except Microcurrent)

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for two devices: Sys*Stim® ME294 and Sonicator Plus 992 (ME992) and Sonicator Plus 994 (ME994). It does not contain information about acceptance criteria or a study proving device performance against such criteria.

The letter is a notification of "substantial equivalence" to devices marketed prior to May 28, 1976, which allows these devices to be marketed. It lists the "Indications For Use" for the Sonicator Plus 992/994, which are:

Therapeutic Ultrasound:

  1. Pain relief
  2. Reduction of muscle spasm
  3. Localized increase in blood flow
  4. Increase range of motion of contracted joints using heat and stretch techniques.

Neuromuscular Stimulation:

  1. Symptomatic relief of chronic intractable pain, acute post-traumatic pain, or acute post-surgical pain (Interferential, Premodulated and Microcurrent waveforms)
  2. Temporary relaxation of muscle spasm (all waveforms except Microcurrent)
  3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles (all waveforms except Microcurrent)
  4. Increase of blood flow in the treatment area (all waveforms except Microcurrent)
  5. Prevention or retardation of disuse atrophy in post-injury type conditions (all waveforms except Microcurrent)
  6. Muscle re-education (all waveforms except Microcurrent)
  7. Maintaining or increasing range of motion (all waveforms except Microcurrent)

Since the document is a 510(k) clearance based on substantial equivalence to predicate devices, it does not detail specific performance studies with acceptance criteria for the new devices. The FDA's determination of substantial equivalence means the new devices are considered as safe and effective as legally marketed predicate devices, without necessarily requiring new clinical trials or performance studies if sufficient data already exists from the predicate device.

Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets them from this document.

§ 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).