SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994

K984142 · Mettler Electronics Corp. · IPF · Feb 9, 1999 · Physical Medicine

Device Facts

• Record ID: K984142
• Device Name: SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994
• Applicant: Mettler Electronics Corp.
• Product Code: IPF · Physical Medicine
• Decision Date: Feb 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

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 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 Story

Sonicator Plus 992 (ME992) and 994 (ME994) are therapeutic devices combining ultrasound and neuromuscular stimulation. Ultrasound component provides deep tissue heating for pain relief, muscle spasm reduction, and increased blood flow. Neuromuscular stimulation component delivers various waveforms (Interferential, Premodulated, Microcurrent) to treat pain, prevent atrophy, and facilitate muscle re-education. Operated by clinicians in clinical settings. Device output allows clinicians to manage musculoskeletal conditions and post-surgical recovery. Benefits include improved range of motion, pain management, and muscle function restoration.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Combination therapeutic ultrasound and neuromuscular stimulation device. Features multiple stimulation waveforms including Interferential, Premodulated, and Microcurrent. Designed for clinical use. Technical specifications and material standards not detailed in provided documentation.

Indications for Use

Indicated for patients requiring therapeutic ultrasound for pain relief, muscle spasm reduction, increased blood flow, or joint range of motion improvement. Also indicated for neuromuscular stimulation for chronic/acute pain relief, muscle spasm relaxation, prevention of post-surgical phlebo-thrombosis, increased blood flow, prevention/retardation of disuse atrophy, muscle re-education, and range of motion maintenance.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/10 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

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

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

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, good 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 In addition, FDA may publish further announcements action. 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 regulations.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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
premarket notification" (21 CFR 807.97). Other gener Other 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,

Mark n Milkus

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 16

Page__________________________________________________________________________________________________________________________________________________________________________

| 510(k) Number (if known): | K984142 |
|---------------------------|----------------------------------------------------------|
| Device Name: | Sonicator Plus 992 (ME992) & Sonicator Plus 994 (ME 994) |

Indications For 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)

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

| Concurrent of CDRH Office of Device Evaluation (ODE) | |
|------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K984142 |

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR
Over-The-Counter Use_(Optional Format 1-2-96)