(63 days)
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Not Found
No
The document describes a therapeutic ultrasound and electrical stimulation device with various waveforms for pain relief and muscle stimulation. There is no mention of AI, ML, or any features that would suggest the use of such technologies.
Yes
The 'Intended Use / Indications for Use' section explicitly states the device is for "THERAPEUTIC ULTRASOUND" and lists conditions it treats, such as pain relief, muscle spasms, and joint contractures.
No
The document describes therapies (therapeutic deep heat, microcurrent, muscle stimulation) for conditions like pain relief, muscle spasms, and disuse atrophy, but it does not mention any diagnostic functions.
No
The intended use and indications for use clearly describe a device that produces therapeutic ultrasound and electrical stimulation, which are hardware-based modalities. The summary does not mention any software-only functionality.
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 therapeutic applications involving the application of energy (ultrasound and electrical currents) to the body for the treatment of various conditions like pain, muscle spasms, and disuse atrophy.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not involve the analysis of such specimens.
- Device Description: While the device description is not found, the listed functions (therapeutic ultrasound and various electrical stimulation waveforms) are consistent with physical therapy or pain management devices, not IVDs.
Therefore, the information clearly indicates a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
THERAPEUTIC ULTRASOUND
Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:
-
- Relief of pain
-
- Muscle Spasms
-
- Joint contractures
But NOT for the treatment of malignancies
- Joint contractures
MICROAMPERAGE PULSED CURRENT INDICATIONS FOR TREATMENT (Microcurrent)
Microcurrent output is indicated for the following conditions:
I) Symptomatic relief of chronic, intractable pain.
2) Management of pain associated with post-traumatic or post-operative conditions.
Quadpolar, Bipolar, Monophasic and Russian Waveforms
This device is indicated for the following conditions:
I) Relaxation of muscle spasms.
2) Prevention or retardation of disuse atrophy.
3) Increasing local blood circulation.
4) Muscle re-education.
5) Maintaining or increasing range of motion.
5) Maniaming of mirgical stimulation of calf muscles to prevent venous thrombosis.
Powered muscle stimulators should only be used under medical supervision for I divertive therapy for the treatment of medical diseases and conditions.
(Quadpolar Interferential and Microamperage Pulsed Current)
I) Symptomatic relief of chronic, intractable pain,
2) Management of pain associated with post-traumatic or post-operative conditions.
Product codes
IPF, GEJ, IMI, IMG, LIH
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
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Description of the training set, sample size, data source, and annotation protocol
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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
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of text surrounding a stylized image of an eagle. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all capital letters. The eagle is depicted with three lines forming its wings and body, giving it a modern and abstract appearance.
OCT 2 5 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Richards Vice President, Director of Regulatory Affairs Rich-Mar Corporation P.O. Box 879 Inola, Oklahoma 74036
Re: K012848 Trade/Device Name: Rich-Mar Winner CM4 Regulation Number: 890.5850, 882.5890, 890.5300, 890.5860 Regulation Name: Powered muscle stimulator Transcutaneous electrical nerve stimulator Ultrasonic diathermy Ultrasound and muscle stimulator Interferential current therapy Regulatory Class: Class II Product Code: IPF, GEJ, IMI, IMG, LIH
Dated: July 31, 2001 Received: August 23, 2001
Dear Mr. Richards:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. David Richards
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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 device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
for Mailh n Melkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 3
510(k) Number (if known):
Device Name: RICH-MAR WINNER CM4
Indications For Use:
THERAPEUTIC ULTRASOUND
Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:
KO12848
-
- Relief of pain
-
- Muscle Spasms
-
- Joint contractures
But NOT for the treatment of malignancies
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N. Millican
(Optional Format 3-10-98)
eneral, Restorative ological Devices
510(k) Number K012848
3
Page 2 of 3
510(k) Number (if known):
RICH-MAR WINNER CM4 Device Name:_
KO12848
Indications For Use:
MICROAMPERAGE PULSED CURRENT INDICATIONS FOR TREATMENT (Microcurrent)
Microcurrent output is indicated for the following conditions: I) Symptomatic relief of chronic, intractable pain. 2) Management of pain associated with post-traumatic or post-operative conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N. Milliken
. Restorative ogical Devices
K 012848 510(k) Number.
(Optional Format 3-10-98)
4
Page 3 of 3
12848
510(k) Number (if known):
RICH-MAR WINNER CM4 Device Name:___
Indications For Use:
Quadpolar, Bipolar, Monophasic and Russian Waveforms
This device is indicated for the following conditions:
I) Relaxation of muscle spasms.
-
Prevention or retardation of disuse atrophy.
-
Increasing local blood circulation.
-
Muscle re-education.
-
Maintaining or increasing range of motion.
-
Maniaming of mirgical stimulation of calf muscles to prevent venous thrombosis.
Powered muscle stimulators should only be used under medical supervision for I divertive therapy for the treatment of medical diseases and conditions.
(Quadpolar Interferential and Microamperage Pulsed Current)
I) Symptomatic relief of chronic, intractable pain,
- Management of pain associated with post-traumatic or post-operative conditions.
(PLE/ NEEDEU)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mach N. Milhuner
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number
(Optional Format 3-10-98)