(83 days)
Not Found
Not Found
No
The provided text describes a therapeutic ultrasound and neuromuscular stimulation device with standard indications for use. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The sections related to AI/ML training and testing data are explicitly marked as "Not Found".
Yes.
The "Intended Use / Indications for Use" section lists several therapeutic applications, such as "Pain relief," "Reduction of muscle spasm," "Increase of blood flow," and "Prevention or retardation of disuse atrophy."
No
The "Intended Use / Indications for Use" section describes therapeutic applications like pain relief, muscle spasm reduction, and increasing blood flow, which are treatments rather than diagnostic purposes.
No
The intended use describes therapeutic ultrasound and neuromuscular stimulation, which are modalities that inherently require hardware components to deliver the therapy. The device description is not found, but the nature of the intended use strongly suggests it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The listed uses are all therapeutic applications involving the direct treatment of the body (pain relief, muscle spasm reduction, increased blood flow, range of motion improvement, etc.). IVDs are used to examine specimens taken from the body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: While the description is "Not Found," the intended uses clearly point to a physical therapy or pain management device, not a diagnostic one.
- Lack of IVD-specific information: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Therapeutic Ultrasound
-
- Pain relief
-
- Reduction of muscle spasm
-
- Localized increase in blood flow
-
- 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)
-
- 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
Not Found
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
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:
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 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 (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
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 (800) 638-2041 or (301) 443-6597 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
2
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
-
- Pain relief
-
- Reduction of muscle spasm
-
- Localized increase in blood flow
-
- 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)
-
- 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)
(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)