WINCO MODEL POWER SERIES LIFT CHAIR

K080533 · Winco, Inc. · INO · Aug 11, 2008 · Physical Medicine

Device Facts

• Record ID: K080533
• Device Name: WINCO MODEL POWER SERIES LIFT CHAIR
• Applicant: Winco, Inc.
• Product Code: INO · Physical Medicine
• Decision Date: Aug 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3110
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of the Winco Inc. Model Power Series Lift Chair is to assist persons who have difficulty rising from a seated position to a standing position.

Device Story

Winco Power Series Lift Chairs are electromechanical devices designed for home or healthcare settings to assist users in transitioning from seated to standing positions. The device consists of two models: the 696 (standard, 300 lbs capacity) and the 905 (bariatric, 600 lbs capacity). Operation is electromechanical, utilizing an actuator to provide lift. The device is intended for use by elderly or physically challenged individuals. It functions as a mobility aid to improve patient independence and reduce physical strain during standing. No complex software or algorithmic processing is involved.

Clinical Evidence

Bench testing only. The actuator meets IEC 60601-1 requirements and upholstery meets CAL 117 flame retardancy standards.

Technological Characteristics

Electromechanical lift chair; includes actuator; upholstery meets CAL 117 flame retardancy; device meets IEC 60601-1 safety standards. Available in two models: standard (300 lbs capacity) and bariatric (600 lbs capacity).

Indications for Use

Indicated for elderly or physically challenged individuals who have difficulty rising from a seated position to a standing position.

Regulatory Classification

Identification

An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.

Special Controls

(1) Appropriate analysis and non-clinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure; (2) Appropriate analysis and non-clinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety; (3) Appropriate analysis and non-clinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device; (4) Appropriate analysis and non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device; (5) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-1, “Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance,” and ANSI/AAMI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Disturbances—Requirements and Tests”) must validate electromagnetic compatibility and electrical safety; (6) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, “Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process,” ANSI/AAMI/ISO 10993-5, “Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity,” and ANSI/AAMI/ISO 10993-10, “Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization”) must validate that the skin-contacting components of the device are biocompatible; (7) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, “Medical Device Software—Software Life Cycle Processes”) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented; (8) Appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable; (9) Appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and (10) Adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment.

Predicate Devices

• Pride Mobility Model C5 Lift Chairs (K707950)

Submission Summary (Full Text)

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510(k) Premarket Notification K080533

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Winco Model Power Series Lift Chair

## 510(k) SUMMARY

Winco, Inc. Model Power Series Lift Chair

AUG 1 1 2008

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Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

Winco, Inc. 5516 Southwest 1st Lane Ocala, Florida 34474

Contact Person: James Ankoviak President and COO Winco, Inc. 5516 Southwest 1st Lanc Ocala, Florida 34474 Phone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: April 15, 2008

Name of Device and Name/Address of Sponsor

Winco Model Power Series Lift Chair

Winco, Inc. 5516 Southwest 1st Lane Ocala, Florida 34474

Common or Usual Name

Lift Chair

#### Classification Name

Chair, Electric, Positioning

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Winco Model Power Series Lift Chair

510(k) Premarket Notification K080533

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### Predicate Device

Pride Mobility Model C5 Lift Chairs (K707950)

#### Intended Use

The intended use of the Winco Inc. Model Power Series Lift Chair is to assist persons who have difficulty rising from a seated position to a standing position.

# Technological Characteristics and Substantial Equivalence

## A. Device Description

The Winco Models Power Series Lift Chairs are electro mechanical devices designed for use in the home or a health care setting. Their intended unnction and use is to raise persons from a seated position to a standing position. They are designed for use by elderly or physically challenged individuals who have difficulty rising to a standing position, when seated.

The Winco Series Lift Chairs consist of two models; the model 696 lift chair and the model 905 lift chair. The model 696 chair is the standard version and is designed to accommodate most users. It is smaller and lighter a vector and 18 905 chair, and has a maximum weight capacity of 300 lbs. The model 905 lift chair is designed for bariatric users. It is wider than the standard 6000 of the chair and has a maximum weight capacity of 600 lbs.

## B. Substantial Equivalence

The Winco, Inc. Model Power Series Lift Chair is substantially equivalent to the Pride Mobility Model C5 Lift Chairs

#### Performance Data

The Winco Power Lift Chair actuator has been tested to and meets the requirements of IEC 60601-1

The upholstery used in the Winco Power Lift Chairs meets the requirements of CAL 117 for Flame Retardancy

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 1 2008

Winco, Inc. % Mr. James Ankoviak President and COO 5516 Southwest First Lane Ocala, Florida 34474

> K080533 Trade/Device Name: Winco Model Power Series Lift Chair Regulation Number: 21 CFR 890.3110 Regulation Name: Electric positioning chair Regulatory Class: Class II Product Code: INO Dated: April 11, 2008 Received: April 21, 2008

Dear Mr. Ankoviak:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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, Or is and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements af the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as et forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000.

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Page 2 - Mr. James Ankoviak

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K080533

Device Name: Winco Model Power Series Lift Chair

Indications for Use: To assist persons who have difficulty rising from a seated position to a standing position.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Deyice Evaluation (ODE)

**(Division Sign-Off)**

Division of General, Restorative, and Neurological Devices

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