(84 days)
Not Found
Not Found
No
The summary describes a device with various electrical stimulation waveforms for pain relief and muscle treatment, but there is no mention of AI, ML, or any related technologies in the provided text.
Yes
The device is intended for symptomatic relief of pain, relaxation of muscle spasm, prevention of phlebo-thrombosis, increase of blood flow, prevention of disuse atrophy, muscle re-education, and maintaining or increasing range of motion, all of which are therapeutic applications.
No
The device's intended uses are all related to treatment and therapy (e.g., pain relief, muscle relaxation, increasing blood flow, prevention of atrophy, muscle re-education, increasing range of motion), not the diagnosis of a condition.
No
The intended use clearly describes a device that delivers electrical stimulation (Interferential, Premodulated, Microcurrent waveforms) for therapeutic purposes. This requires hardware to generate and deliver these waveforms to the patient, making it a hardware-based device with potential software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to physical therapy and pain management through electrical stimulation applied to the body. These are therapeutic applications, not diagnostic tests performed on samples taken from the body.
- Device Description: While the description is "Not Found," the intended uses clearly point to a device that interacts with the patient's body externally.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition based on laboratory analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely different.
N/A
Intended Use / Indications for Use
-
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential, Premodulated and Microcurrent waveforms)
-
- Temporary relaxation of muscle spasm, (all waveforms except Microcurrent)
-
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles, (all waveforms except Microcurrent)
-
- Increase of blood flow in the treatment area(all waveforms except Microcurrent)
-
- Prevention or retardation of disuse atrophy in post-injury type conditions, (all waveforms except Microcurrent)
-
- Muscle re-education, (all waveforms except Microcurrent)
-
- Maintaining or increasing range of motion, (all waveforms except Microcurrent)
Product codes
IPF, LIH, GZJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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:
1
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
2
Attachment Th
Page of
510(k) Number (if known):
Sys*Stim 294 (ME294) Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
-
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential, Premodulated and Microcurrent waveforms)
-
- Temporary relaxation of muscle spasm, (all waveforms except Microcurrent)
(98 4114
-
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles, (all waveforms except Microcurrent)
-
- Increase of blood flow in the treatment area(all waveforms except Microcurrent)
-
- Prevention or retardation of disuse atrophy in post-injury type conditions, (all waveforms except Microcurrent)
-
- Muscle re-education, (all waveforms except Microcurrent)
-
- 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)