(321 days)
Not Found
None
No
The summary does not mention AI, ML, or any related concepts, and the device description is for a standard muscle stimulator.
Yes
The device is indicated for conditions such as "Relaxation of muscle spasms," "Prevention or retardation of disuse atrophy," "Increasing local blood circulation," and "Maintaining or increasing range of motion," all of which are therapeutic purposes.
No
The device's stated function is to apply electrical current for therapeutic purposes (e.g., muscle relaxation, blood circulation), not to diagnose a condition.
No
The device description explicitly states "ROLOR POWERED MUSLCE STIMULATOR GP-8016M," which indicates a hardware device that applies electrical current. The intended use also describes applying electrical current to electrodes, further confirming a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes applying electrical current to a patient's skin for therapeutic purposes (muscle stimulation, relaxation, circulation, range of motion). This is a direct interaction with the patient's body for treatment, not for examining specimens from the body to diagnose or monitor conditions.
- Device Description: The description "POWERED MUSLCE STIMULATOR" aligns with a device used for physical therapy or rehabilitation, not for laboratory testing.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the ROLOR POWERED MUSLCE STIMULATOR GP-8016M is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Specific indications: used to apply an electrical current to electrodes on . patient's skin to function as:
Relaxation of muscle spasms.
Prevention or retardation of disuse atrophy
Increasing local blood circulation.
Maintaining or increasing range of motion.
Product codes
IPF
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
Not Found
Key Metrics
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract image of a human figure, with three lines representing the head, body, and legs.
Public Health Service
DEC 02 2002
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Dr. Jen. Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, Taiwan, ROC
Re: K020130
Trade/Device Name: ROLOR POWERED MUSLCE STIMULATOR GP-8016M Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II -Product Code: IPF Dated: October 18, 2002 Received: October 25, 2002
Dear Dr. Jen:
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic
1
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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) 594-4639. 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,
Miriam C. Provost
Cor 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
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ROLOR ELECTRONICS CORPORA ANIDAD HEALTH INDUSTRIES
No. 274, Nanking E. Road, Sec: 5, Taipei, Taiwan, R.O.C. P.O. Box 46-379 TEL: 886-2-27682174-5, FAX: 886-2-27605922
Email:
| Applicant: | Rolor Electronics Corp. |
|---|---|
| 510(k) Number (if known): | K020130 |
| Device Name: | ROLOR POWERED MUSCLE STIMULATOR GP-8016N |
Indications for use:
- Specific indications: used to apply an electrical current to electrodes on . patient's skin to function as:
Relaxation of muscle spasms.
Prevention or retardation of disuse atrophy
Increasing local blood circulation.
Maintaining or increasing range of motion.
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, office of Device Evaluation (ODE )
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109 ) |
OR
| Over – The – Counter – Use | |
|---|---|
| ( Optional Format 1-2-96 ) |
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices00 No No No2 0130