(82 days)
Not Found
Not Found
No
The description focuses on mechanical and electrical components for massage and tension release, with no mention of AI or ML terms or functionalities.
No.
The device's intended use is to release muscle tension and deliver soothing massage, which are generally considered wellness or comfort benefits rather than therapeutic medical treatments.
No
Explanation: The device is described as a massager that uses rollers, vibration, and heat to release muscle tension. There is no indication that it is used to diagnose any medical condition.
No
The device description explicitly mentions a "roller mechanism and electric motors coupled with vibration and optional heat," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "release muscle tension and deliver soothing massage" through physical manipulation (roller mechanism, vibration, heat). This is a therapeutic or wellness application, not a diagnostic one.
- Device Description: The description focuses on the mechanical and physical aspects of the device and its function on the patient's body. It does not involve analyzing biological samples (blood, urine, tissue, etc.) which is the core of IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Quest Intersegmental Roller Table does not fit this description.
N/A
Intended Use / 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.
Product codes
JFB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical area to the lumbar area
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 (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
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human figures.
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)