AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM

K994072 · Amylior, Inc. · ITI · Jan 13, 2000 · Physical Medicine

Device Facts

• Record ID: K994072
• Device Name: AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM
• Applicant: Amylior, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Jan 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of the device is to provide posterior tilting for positioning and pressure relief in a powered wheelchair.

Device Story

AmySystems PTS50CG is a power tilt system for powered wheelchairs. It provides posterior tilting functionality to assist with patient positioning and pressure relief. Operated by the wheelchair user or caregiver, the system adjusts the seat angle to redistribute pressure, potentially reducing the risk of pressure sores. It functions as an add-on or integrated component of a powered mobility device.

Clinical Evidence

Bench testing only.

Technological Characteristics

Power tilt mechanism for wheelchair seating; provides posterior seat angle adjustment; electromechanical actuation.

Indications for Use

Indicated for patients requiring posterior tilting for positioning and pressure relief while using a powered wheelchair.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 3 2000

Mr. Sylvain Dugas President Amylior Inc. 6 Antoine-Henault Notre-Dame-de-L'lle Perrot, Quebec Canada, J7V 7M3

Re: K994072

> Trade Name: AmySystems PTS50CG-50° Power Tilt System Regulatory Class: II Product Code: ITI Dated: November 30, 1999 Received: December 2, 1999

Dear Mr. Dugas:

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. Sylvain Dugas

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 [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,

Mark N. Milherson

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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## 8.1.1. Statement of indications for use

K 994072 510(K) number (if known): ַ

510(K) hamber (II known);
Device Name: AmySystems PTS50CG Weight Shift Power Tilt System

Indications for use:

The intended use of the device is to provide posterior tilting for positioning and pressure relief in a powered wheelchair.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Murk M. Mulkeison

Prescription Use (per 21 CFR 801.109) OR

Over-The-Counter Use