(82 days)
The Quest Intersegmental Roller Table uses a roller mechanism and electric motors coupled with vibration and optional heat to release muscle tension and deliver soothing massage by the movement of the roller carriage back and forth from the cervical area to the lumbar area of the patient.
The Quest Intersegmental Roller Table uses a roller mechanism and electric motors coupled with vibration and optional heat to release muscle tension and deliver soothing massage by the movement of the roller carriage back and forth from the cervical area to the lumbar area of the patient.
The provided text is a 510(k) clearance letter from the FDA for a device called "Quest Intersegmental Roller Traction Table". This document does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, or ground truth establishment.
The letter primarily:
- Acknowledges receipt of the 510(k) notification.
- States that the device is substantially equivalent to a legally marketed predicate device.
- Grants permission to market the device, subject to general controls and other FDA regulations.
- Identifies the product as a Class II device.
- Provides contact information for regulatory questions.
The "Indications For Use" section describes how the device functions ("uses a roller mechanism and electric motors coupled with vibration and optional heat to release muscle tension and deliver soothing massage by the movement of the roller carriage back and forth from the cervical area to the lumbar area of the patient") but does not quantify performance or set acceptance criteria.
Therefore, I cannot provide the requested table and study details based on the input document. The document is a regulatory approval letter, not a device performance study report.
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Public Health Service
JAN - 3 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gerald S. Auslander Managing Member Icon International LLC 300 Ozark Trail Drive, #207 C Ellisville, Missouri 63011
Re: K993461
Trade Name: Ouest Intersegmental Roller Traction Table Regulatory Class: II Product Code: JFB Dated: October 5, 1999 Received: October 13, 1999
Dear Mr. Auslander:
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 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). 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 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. Gerald S. Auslander
This letter will allow you to begin marketing your device as described in your 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 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 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/dsma/dsmamain.html".
Sincerely yours,
Picard J. Lager
- for James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K993461
Device Name: Quest Intersegmental Roller Traction Table
Indications For Use:
The Quest Intersegmental Roller Table uses a roller mechanism and electric motors coupled with vibration and optional heat to release muscle tension and deliver soothing massage by the movement of the roller carriage back and forth from the cervical area to the lumbar area of the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pierre G. S. Lygum
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 890.5880 Multi-function physical therapy table.
(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).