MERITS MODEL E SERIES LIFT CHAIRS

K060212 · Merits Health Products Co., Ltd. · INO · Mar 7, 2006 · Physical Medicine

Device Facts

• Record ID: K060212
• Device Name: MERITS MODEL E SERIES LIFT CHAIRS
• Applicant: Merits Health Products Co., Ltd.
• Product Code: INO · Physical Medicine
• Decision Date: Mar 7, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3110
• Device Class: Class 2

Intended Use

The Merits Model E Series Lift Chairs are intended to assist elderly and/or physically challenged persons, who have difficulty rising from a seated position to a standing position.

Device Story

The Merits Model E Series Lift Chair is an electric positioning chair designed to assist individuals with mobility limitations. The device consists of an upholstered fabric chair assembly mounted on a welded steel frame. It utilizes one or two motorized linear actuators to adjust the chair's position, operated by a handheld, push-button pendant control. Powered by standard AC wall outlets, the chair is intended for use by elderly or physically challenged persons to facilitate the transition from a seated to a standing position. The device functions as a mechanical aid to improve patient independence and mobility.

Clinical Evidence

Bench testing only. Results confirm the device meets specifications and is substantially equivalent to the predicate device.

Technological Characteristics

Upholstered fabric chair assembly; welded steel lifting frame; motorized linear actuators; handheld push-button pendant control; AC power source.

Indications for Use

Indicated for elderly and/or physically challenged persons having difficulty rising from a seated 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

• GOLDEN POWER LIFT CHAIR Model PR355M (K880800)

Submission Summary (Full Text)

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Kobo212

## MAR 7 -2006

9.0 510(K) Summary

## "510(k) SUMMARY"

- 9.1 Trade/Proprietary Name: Merits Model E Series Lift Chair
- 9.2 Common/Usual Name:

Lift Chair

- 9.3 Classification Name:
- Chair, Electric, Positioning
- 9.4 Comparison to Currently Marketed Devices

The Merits Health Products Model E Series Lift Chairs are substantially equivalent to the GOLDEN POWER LIFT CHAIR Model PR355M (K880800).

- તે. રે Device Description
The Merits Pioneer Model E Series Lift Chair operates using standard AC Power from a wall outlet. All models consist basically of an upholstered chair assembly, which is constructed of fabric, and fastened to a lower frame, lifting assembly, which is constructed of welded steel. Additionally, all include one/or two motorized linear actuators which are used to position the chair assembly, and a hand held, push button type pendant control, which is used to engage actuator motion and vary the chair's position.

- 9.6 Intended use
The Merits Model E Series Lift Chairs are intended to assist elderly and/or physically challenged persons, who have difficulty rising from a seated position to a standing position.

- 9.7 Technological Characteristics
Merits Model E Series Lift Chairs are equivalent in functions to the legally marketed predicate device. The devices both use motorized linear actuator which is used to position the chair assembly, and a hand held, push button type pendant control, which is used to engage actuator motion and vary the chair's position. This technology is well established and has been used in other legally marketed products. There are no major technological differences.

- 9.8 Performance Data
The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.

- ਰੇ 'ਰੇ Conclusion
Based on the design, performance specifications and testing and intended use, the Merits Model E Series Lift Chairs are substantially equivalent to the currently marketed device, GOLDEN POWER LIFT CHAIR Model PR355M. (K880800)

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

2006 MAR 7

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Merits Health Products Co., Ltd. C/O Mr. Steve Chao Chief Executive Officer 9, Road 36 Taichung Industrial Park Taichung, Taiwan R.O.C

Re: K060212

Trade/Device Name: Merits Health Products Model E series Lift Chair Regulation Number: 21 CFR 890.3110 Regulation Name: Electric Positioning Chair Regulatory Class: II Product Code: INO Dated: January 26, 2006 Received: January 30, 2006

Dear Mr. Chao:

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. Drug, 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 of 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 set

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## Page 2 - Mr. Steve Chao

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Helmut Werner wo

Mark N. Melkerson Acting 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 STATEMENT

510(k) File Number:

Device Name:

K060212

Merits Health Products Model E Series Lift Chair

Indications For Use:

The Merits Model E Series Lift Chairs are intended to assist elderly and/or physically challenged persons, who have difficulty rising from a seated position to a standing position.

Prescription Use _ (Per 21 CFR 801 Subpart D)

AND/OR

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K060212