SYS STIM 294, MODEL ME 294

• K Number: K984114
• Device Name: SYS STIM 294, MODEL ME 294
• Manufacturer: METTLER ELECTRONICS CORP.
• Date Cleared: 1999-02-09 ( 84 days)
• Product Code: IPF , GZJ , LIH
• Regulation Number: 890.5850
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: K070888 , K192746

Intended Use

• 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)

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for several medical devices, including the Sys*Stim® ME294. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510 (k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to devices marketed in interstate commerce prior to May 28, 1976... "

This means the FDA found the device "substantially equivalent" to predicate devices already on the market, rather than requiring a new study with acceptance criteria. The document focuses on regulatory compliance and the legal right to market the device, not on clinical performance metrics or studies.

Therefore, requested information, such as acceptance criteria tables, sample sizes, expert qualifications, study methodologies, and specific performance outcomes, cannot be extracted from the provided text.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

Mr. Robert E. Fleming Director of Operations and Requlatory Affairs Mettler Electronics Corporation 1333 South Claudina Street Anaheim, California 92805

Re: K984114 Sys*Stim® ME294 Trade Name: K984142 Sonicator Plus 992 (ME992) and Sonicator Trade Name: Plus 994 (ME994) Requlatory Class: II Product Codes: IPF, LIH, and GZJ Dated: November 16, 1998 November 17 and 18, 1998 Received:

Dear Mr. Fleming:

We have reviewed your Section 510 (k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note:

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Page 2 - Mr. Robert E. Fleming

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your devices as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to ene regaración Chercroa, "MisFanding by Sother general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mr. M. M.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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Attachment Th

Page of

510(k) Number (if known):

Sys*Stim 294 (ME294) Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

• 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)

(98 4114

• 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)

84114: Mark N Millan

eneral Restorative Devices

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

Concurrent of CDRH Office of Device Evaluation (ODE)

Prescription Use X
(Per 21 CFR 801.109)

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).