(93 days)
AS A POWERED MUSCLE STIMULATOR
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
AS A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
- SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN
AS AN INTERFERENTIAL CURRENT STIMULATOR
- SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN
- SYMPTOMATIC RELIEF OF ACUTE PAIN
Not Found
The provided document is an FDA 510(k) clearance letter for the MEDS-4-INF+ Stimulator, determining its substantial equivalence to legally marketed predicate devices. It lists the approved indications for use as a Powered Muscle Stimulator, a Transcutaneous Electrical Nerve Stimulator, and an Interferential Current Stimulator.
However, this document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, nor any of the other specific details requested in the prompt (sample sizes, ground truth, expert qualifications, etc.).
Therefore, I cannot provide the requested information based on the input document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 03 2003
Mr. C. A. Teklinski Attorney Medical Equipment Device Specialists 9811 W. Charleston #2387 Las Vegas, NV 89117
Re: K032055 Trade/Device Name: MEDS-4-INF+ Stimulator Regulation Number: 21 CFR 882.5890, 21 CFR 890.5850 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief, Powered muscle stimulator Regulatory Class: II Product Code: GZJ, IPF, LIH Dated: June 27, 2003 Received: July 11, 2003
Dear Mr. Teklinski:
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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. C. A. Teklinski
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Sincerely yours,
Mark N. Millman
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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MEDS-4-INF+ STIMULATOR
(510 (k) #_ K (> 3 205 == )
INDICATIONS FOR USE
THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS :
AS A POWERED MUSCLE STIMULATOR
- Relaxation of muscle spasms 1.
- Prevention or retardation of disuse atrophy 2.
- Increasing local blood circulation 3 .
- 4 . Muscle re-education
- Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis
- Maintaining or increasing range of motion 6.
AS A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
-
- SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN
AS AN INTERFERENTIAL CURRENT STIMULATOR
- SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN 1.
- SYMPTOMATIC RELIEF OF ACUTE PAIN 2.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
f Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032055
Prescription Use √
(Per 21 CFR 801.109)
OR Over-The-Counter Use
000109
§ 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).