(67 days)
This device is a 'combination' device and has the same indications for use as two different types of predicate devices.
High Volt Pulsed Galvanic Stimulators and Neuromuscular Electrical Stimulators share the same indications for use as listed below.
- Relaxation of muscle spasms ●
- Prevention or retardation of disuse atrophy .
- Increasing local blood circulation ●
- Muscle re-education .
- Maintaining or increasing range of motion ●
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis ●
Interferential Stimulators have one additional indication for use:
Symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post traumatic and post-surgical pain relief.
Not Found
This document is a 510(k) clearance letter from the FDA for a device named "Surgi Stim". It confirms that the device is substantially equivalent to predicate devices and can be marketed. However, this document does not contain any information regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, or details of a study that proves the device meets specific performance criteria.
The letter focuses on the regulatory clearance process and states the "Indications For Use" for the Surgi Stim device which is a combination of High Volt Pulsed Galvanic Stimulators, Neuromuscular Electrical Stimulators, and Interferential Stimulators.
Therefore, I cannot answer your specific questions based on the provided text. The document does not describe a study or provide performance data.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1998
Mr. Robert R. Thauer Vice President of Operations Vision Quest Industries, Inc. 1675 Scenic Avenue Costa Mesa, California 92626
Re: K982388 Trade Name: Surgi Stim Requlatory Class: II Product Codes: IPF and LIH July 6, 1998 Dated: Received: July 9, 1998
Dear Mr. Thauer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 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 (Premarket Approval), 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 895. ನ್ನ 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 Druq 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 device in the Federal Register. Please note: 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.
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Page 2 - Mr. Robert R. Thauer
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asboing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets produced of mits 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 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" (21 CFR 807.97). 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,
Ph.D., M.D. Celia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
This device is a 'combination' device and has the same indications for use as two different types of predicate devices.
High Volt Pulsed Galvanic Stimulators and Neuromuscular Electrical Stimulators share the same indications for use as listed below.
- Relaxation of muscle spasms ●
- Prevention or retardation of disuse atrophy .
- Increasing local blood circulation ●
- Muscle re-education .
- Maintaining or increasing range of motion ●
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis ●
Interferential Stimulators have one additional indication for use:
Symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post traumatic and post-surgical pain relief.
Prescription Use
(Per 21 CFR 801.109)
bcolly
(Division Division of General Rest 510(k) Number
§ 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).