ELECTRIC SEAT LIFT CHAIR

K961663 · Ken Kemmerer · INO · May 29, 1996 · Physical Medicine

Device Facts

• Record ID: K961663
• Device Name: ELECTRIC SEAT LIFT CHAIR
• Applicant: Ken Kemmerer
• Product Code: INO · Physical Medicine
• Decision Date: May 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3110
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

Lift chair; assists users in transitioning between seated and standing positions. Device consists of oak wood, foam, fabric, and steel frame (1"x1" 16-gauge and 1"x2" 14-gauge steel). Operates via UL-listed and CSA-approved motor and switch components. Used in home or clinical settings; operated by patient or caregiver. Provides mechanical lift functionality to improve mobility and independence for users with limited physical strength.

Clinical Evidence

No clinical data; reliance on 25-year market history of similar products and established safety of components.

Technological Characteristics

Materials: oak wood, foam, fabric, 16-gauge (1"x1") and 14-gauge (1"x2") steel. Energy: electric motor (UL listed, CSA approved). Form factor: lift chair. Connectivity: none. Sterilization: N/A.

Indications for Use

Indicated for individuals requiring assistance with sitting or standing, supporting a maximum weight capacity of 300 lbs.

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.

Submission Summary (Full Text)

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MAY 29 1988
K961663

# SUMMARY OF SAFETY AND EFFECTIVENESS

You will find enclosed literature on Five (5) Lift chair companies already marketing very similar products.

As you will see the motors and switches are all UL listed and CSA approved on each of the five different chairs. I will be using the same motor and switch made by Hubbell Corp.

The lift chair market has been in existence for 25 years, so the product has been fully tested through many cycles.

My product is constructed of the same materials, as that of all the lift chair manufacturers I have provided. The chairs consist of oak wood, foam and fabric. The steel frame is constructed of 1"x 1", 16 gauge steel and also 1"x 2" 14 gauge steel.

The weight capacity of all their units is 300 lbs. which will be the same on mine.

The frame bases on all the units are basically the same width for stability. My frame will be the same.

As you can see my products are actually the same as the products of the five manufacturers enclosed.

As a summary of safety, my products do not raise any safety requirements.

Thank you very much and if you have any questions, my telephone number is (717)-822-8629.

My address is as follows:
788 Keating Street
Wilkes Barre Twp, PA. 18702