← Product Code [JFB](/productcode/JFB) · K971046

# HANDIFLEX (K971046)

_Handiflex Corp. · JFB · Sep 16, 1997 · Physical Medicine · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K971046

## Device Facts

- **Applicant:** Handiflex Corp.
- **Product Code:** [JFB](/productcode/JFB.md)
- **Decision Date:** Sep 16, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5880
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine
- **Attributes:** Therapeutic

## 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.

## Device Story

Handiflex is a tilt table device designed to transition users from a horizontal to a near-vertical position. It facilitates physical therapy by allowing users to exercise various muscle groups at adjustable angles of inclination. The device aims to assist in muscle redevelopment and the improvement of joint range of motion. It is intended for over-the-counter use.

## Technological Characteristics

Tilt table mechanism for postural adjustment and physical exercise. Manual operation.

## Regulatory 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.

## Submission Summary (Full Text)

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HUMAN SERVICES CENTER
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

# SEP 16 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 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 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 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. 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 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,

![img-0.jpeg](img-0.jpeg)

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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FROM : HANDIFLEX CORPORATION
PHONE NO. : 954 370 1578
Sep. 15 1997 03:16PM P2

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 Device Evaluation (ODE)
![img-1.jpeg](img-1.jpeg)

Prescription Use
(Per21 CFR 801.109) ☐ OR ☑ Over-The-Counter Use

(Optional Format 1-2-96)

L 2

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**Source:** [https://fda-staging.innolitics.com/device/K971046](https://fda-staging.innolitics.com/device/K971046)

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