(179 days)
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Not Found
No
The summary describes a mechanical tilt table with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes
The device is described as providing the means for the user to "redevelop muscles" or "increase the range of motion of the joints," which are therapeutic applications.
No
The device description states its purpose is for exercising muscle groups and increasing range of motion, not for diagnosing medical conditions.
No
The device is described as a "tilt table," which is a piece of physical hardware used for rehabilitation. There is no mention of any software component being the primary or sole medical device.
Based on the provided information, the Handiflex tilt table is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health.
- The Handiflex tilt table is a physical therapy device. Its intended use is to help users redevelop muscles and increase joint range of motion through physical exercise and positioning. It does not involve the analysis of biological specimens.
The description clearly indicates a device used for physical rehabilitation and exercise, not for diagnostic testing using in vitro methods.
N/A
Intended Use / Indications for Use
Handiflex is a tilt table which provide the means for the user to go from the horizontal to the near vertical position to access components for redeveloping muscles or increasing the range of motion of the joints.
The user can exercise different muscle groups at different degrees of inclination.
Product codes
JFB
Device Description
Handiflex is a tilt table
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
muscles, joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
user
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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 1997
Mr. Jose Bruno Roman ·President & CEO Handiflex Corporation 4611 South University Drive, Suite 432 Davie, Florida 33328
- Re: K971046 HANDIFLEX Regulatory Class: II Product Code: JFB Dated: June 17, 1997 Received: June 19, 1997
Dear Mr. Roman:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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. Jose Bruno Roman
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 labelinq 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,
Celia M. Witten, Ph.D., M.D. 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):
Device Name: HANDIFLEX
Indications for Use:
Handiflex is a tilt table which provide the means for the user to go from the horizontal to the near vertical position to access components for redeveloping muscles or increasing the range of motion of the joints.
The user can exercise different muscle groups at different degrees of inclination.
(please do not write below this line-continue on another page if needed)
concurrence of CDRH, Office of Deyice Evaluation (ODE)
Willingham
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971044
Prescription Use (Per21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)