TILT MASTER CG SYSTEM (CENTER OF GRAVITY), TILT-N-SPACE-SEAT

K972564 · Mechanical Application Designs, Inc. · ITI · Aug 25, 1997 · Physical Medicine

Device Facts

• Record ID: K972564
• Device Name: TILT MASTER CG SYSTEM (CENTER OF GRAVITY), TILT-N-SPACE-SEAT
• Applicant: Mechanical Application Designs, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Aug 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

THE TILTMASTER KIT DESIGN IS INTENDED FOR USE ON A POWER AND MANUAL WHEELCHAIR TO PROVIDE PATIENTS WITH POSTERIOR TILT FOR POSITIONING AND SEATING PRESSURE RELIEF.

Device Story

The Tilt Master CG System is an aftermarket kit designed to convert standard power or manual wheelchairs into power recline systems. The kit includes a linear actuator (900 lb capacity), aluminum and steel brackets, a wiring harness, and a mercury switch driver lockout. The system utilizes a center-of-gravity design that shifts the patient's center of gravity forward by 6 inches during tilt, providing stability within a 5 to 55-degree tilt range. A mercury switch disables the wheelchair drive function when tilted beyond 15 degrees. In the event of a catastrophic failure, a safety nut on the actuator allows the user to return the seat to the drive position and permanently disables the tilt mechanism. The device is operated by the wheelchair user to facilitate pressure relief and positioning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Aluminum and steel brackets. Actuation: Linear actuator (Linak) with 6-inch travel. Sensing: Mercury switch for tilt-angle lockout. Connectivity: None. Power: Electric (wheelchair battery). Form factor: Aftermarket kit including actuator, brackets, wiring, and padded contoured back/headrest.

Indications for Use

Indicated for patients using power or manual wheelchairs requiring posterior tilt for positioning and seating pressure relief.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• E&J VORTEX TILT-N-SPACE CENTER OF GRAVITY (K972564)
• FOLIO TS90, TS95 (K972564)
• VECTOR MOBILITY BASE LINK (K972564)

Submission Summary (Full Text)

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## "510K SUMMARY"

AUG 25 8

TILT-N-SPACE

DALVA R. ALEXANDER MECHANICAL APPLICATION DESIGNS, INC. 6819 HWY 90 BLVD.. SUITE 680 KATY, TEXAS 77491 [phone] [phone] FAX

K972564

CONTACT: DALVA R. ALEXANDER DATE PREPARED: MARCH 15, 1997

| NAME OF DEVICE: | TILT MASTER CG SYSTEMS (CENTER OF<br>GRAVITY) | | |
|-----------------------------|-----------------------------------------------|---|------------------------------------------|
| TRADE NAME: | TILT-N-SPACE CENTER OF GRAVITY<br>SYSTEM | | |
| PROPRIETARY NAME: | CG SYSTEM | | |
| CLASSIFICATION NAME: | PHYSICAL MEDICINE/POWERED<br>WHEELCHAIR | | |
| PRODUCT CODE: | 890-3860 | | |
| SUBSTANTIAL<br>EQUIVALENCE: | E&J | - | VORTEX TILT-N-SPACE<br>CENTER OF GRAVITY |
| | FOLIO | - | TS90, TS95 |
| | VECTOR<br>MOBILITY | - | BASE LINK |

DESCRIPTION: GRAVITY), IS AN AFTERMARKET KIT CONSISTING OF A LINEAR ACTUATOR WITH 900 POUNDS CAPACITY, ALUMINUM AND STEEL BRACKETS, WIRING HARNESS TO SUPPLY VOLTAGE TO THE ACTUATOR, AND A MERCURY SWITCH DRIVER LOCKOUT WHICH RENDERS THE WHEELCHAIR INOPERABLE WHEN TILTED BEYOND 15 DEGREES. THE CG SYSTEM KIT IS DESIGNED TO CONVERT A POWERED OR MANUAL STANDARD WHEELCHAIR TO A POWER RECLINE. THE TILT MASTER CG SYSTEM USES A CENTER OF GRAVITY DESIGN TO MOVE THE PATIENTS CENTER OF GRAVITY FORWARD 6" AS THE SYSTEM TILTS. THIS PROVIDES ADDED SECURITY WHEN IN THE TILTED POSITION. THE TILT MASTER CG SYSTEM ALLOWS THE USER TO HAVE 5 TO 55 DEGREE RANGE OF TILT. THE TILT MASTER CG SYSTEM IS DESIGNED SO IF ANY CATASTROPHIC FAILURE OCCURS WHILE THE SEAT IS IN THE TILT POSITION, THE SAFETY NUT ON THE ACTUATOR WILL ALLOW THE DRIVER TO PUT THE SEAT BACK ON THE DRIVE POSITION AND WILL DISABLE THE TILT MECHANISM. THE

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DRIVER WILL BE UNABLE TO PUT THE SYSTEM IN THE TILT POSITION ONCE THIS OCCURS.

INTENDED USE: THE TILT MASTER CG SYSTEM DESIGN IS INTENDED FOR USE ON A POWER OR MANUAL STANDARD WHEELCHAIR TO PROVIDE POWER RECLINE FOR POSTERIOR TILT FOR POSITIONING AND SEATING PRESSURE RELIEF.

TECHNOLOGICAL CHARACTERISTICS: THE E&J SYSTEM HAS A LIMIT OF 3" OF LINEAR TRAVEL. THEIR SYSTEM ROLLS ON CAM MEANS (ROLLS ON A MACHINED OUT GROOVE). E&J USES AN ACTUATOR BY MOTION. THE TILTMASTER CG SYSTEM HAS A 6" LINEAR MOTION, HAS AN OIL LIGHT BEARING ROLLER THROUGH A TROUGH MEANS, USES A HIGHER QUALITY MADE ACTUATOR BY LINAK WHICH ALSO HAS AN EXTRA 2 YEAR WARRANTY. TILTMASTER ALSO SENDS OUT A PADDED COUNTOURED BACK AND HEADREST WITH ALL OUR SYSTEMS.

NON CLINICAL TESTING: PLEASE REFER TO THE FOLLOWING ATTACHMENT.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Dalva R. Alexander Chief Executive Officer Mechanical Application Designs, Inc. 6819 Highway 90 Boulevard, Suite 680 Katy, Texas 77494

AUG 2 5 1997

Re: K972564 Tilt Master CG System (Center of Gravity) Tilt-N-Space-Seat Regulatory Class: II Product Code: ITI Dated: March 15, 1997 Received: July 9, 1997

Dear Ms. Alexander:

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 regulations affecting your device can be found in the Code of Federal Requlations, 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 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 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 - Ms. Dalva R. Alexander

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ia 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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## "STATEMENT FOR INDICATION FOR USE"

## THE TILTMASTER KIT DESIGN IS INTENDED FOR USE ON A POWER AND MANUAL WHEELCHAIR TO PROVIDE PATIENTS WITH POSTERIOR TILT FOR POSITIONING AND SEATING PRESSURE RELIEF.

**Over-the-Counter Use**

De Colle

Divisi eneral Restorative De 510(k) Numb