SYS STIM 294, MODEL ME 294

K984114 · Mettler Electronics Corp. · IPF · Feb 9, 1999 · Physical Medicine

Device Facts

• Record ID: K984114
• Device Name: SYS STIM 294, MODEL ME 294
• 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

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

Sys*Stim ME294 is an electrotherapy device delivering Interferential, Premodulated, and Microcurrent waveforms. Used in clinical settings by healthcare professionals for pain management and muscle rehabilitation. Device applies electrical stimulation to patient tissue to induce muscle contraction or modulate pain signals. Output affects clinical decision-making by providing non-pharmacological pain relief and physical therapy adjuncts. Benefits include improved range of motion, reduced muscle atrophy, and prevention of post-surgical complications like phlebo-thrombosis.

Clinical Evidence

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

Technological Characteristics

Electrotherapy device utilizing Interferential, Premodulated, and Microcurrent waveforms. Operates via electrical stimulation. Intended for professional clinical use. No specific materials or software architecture details provided.

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable, acute post-traumatic, or acute post-surgical pain; temporary muscle spasm relaxation; prevention of post-surgical phlebo-thrombosis; increased local blood flow; prevention/retardation of disuse atrophy; muscle re-education; and maintenance/increase of range of motion.

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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Public Health Service

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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

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Concurrent of CDRH Office of Device Evaluation (ODE)

Prescription Use X
(Per 21 CFR 801.109)