LIFT CHAIR, MODEL T3

K091578 · Pride Mobility Products Corp. · INO · Dec 2, 2009 · Physical Medicine

Device Facts

• Record ID: K091578
• Device Name: LIFT CHAIR, MODEL T3
• Applicant: Pride Mobility Products Corp.
• Product Code: INO · Physical Medicine
• Decision Date: Dec 2, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intended Use of the Pride Mobility T3 Lift Chair is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.

Device Story

T3 Lift Chair is an upholstered electric positioning chair with a welded steel frame. It utilizes a dual-actuator system powered by a low-voltage DC motor (24/39V DC) converted from standard household AC (110V/240V). The user operates the chair via a hand control switch to transition between reclining, sitting, and standing positions. The dual-actuator design allows independent movement of chair components for improved comfort. The device is intended for use in home or clinical settings to assist individuals with mobility limitations in standing up. It includes an external transformer and battery backup for safety. The chair benefits patients by providing mechanical lift assistance, reducing the physical effort required to transition from a seated to a standing position.

Clinical Evidence

No clinical data. Bench testing only, including flammability (CAL 117, BS5852), electromagnetic emissions/immunity (EN 61000-6-3, EN 61000-6-1), electrical safety (EN60601-1), and mechanical fatigue/cycle/impact/downward force testing.

Technological Characteristics

Welded steel frame; foam and fabric upholstery compliant with CAL 117 and BS5852; dual-actuator DC motor system (24/39V DC); external transformer with battery backup; hand control switch; electrical safety per EN60601-1; electromagnetic compatibility per EN 61000-6-3/6-1.

Indications for Use

Indicated for persons having 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 C5 (K070950)

Submission Summary (Full Text)

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K091528

Research & Development 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX [phone] www.pridemobility.com

Exhibit 1

# 510(k) Summary Pride Mobility Products Corporation T3 Lift Chair

### Submitter's Name & Address:

Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter. Pa. 18643 Phone: [phone] Facsimile: [phone]

#### Contact Person:

Thomas Schappert Official Correspondent

#### Date Prepared:

05-08-09

#### Name of Device and Proprietary Name:

T3 Lift Chair / Pride Mobility Products Corporation

## Common or Usual Name:

Electric Lift Chair

### Classification Name:

Electric Positioning Chair per 21 CFR, 890.3110

### Product Code:

INO

### Comparison to Predicate Devices:

The T3 Lift Chair is substantially equivalent to the Pride Mobility C5 (K070950) when comparing construction and performance. The performance characteristics and positioning of components are similar to achieve the same Intended Use. The T3 offers a dual actuator system vrs. one actuator on the C5; the dual actuator system enables the chair components to move independently to create additional comfort positioning.

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Image /page/1/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, sans-serif font, with the letters slightly overlapping. Below the word "Pride", the words "Mobility Products Corp." are written in a smaller, sans-serif font. The logo is black and white.

Research & Development 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX [phone] www.pridemobility.com

#### Device Description:

The Pride Mobility T3 Lift Chair is an upholstered chair having welded steel frame construction. The chair upholstery (foam and fabric) are compliant to Cal 117 and BS5852 Flammability requirements. The upholstered chair is assembled to a weldedsteel lifting frame mechanism, and a Hand Control Switch Device engages motor / actuators to position the chair to recline, sitting, or standing positions. The system is a low voltage DC motor system that reduces the standard household alternating current of 110V AC / 240V AC to direct current (24 / 39V DC). The electrical components include the external transformer with battery backup, two motor / actuators, and the Hand Control.

#### Intended Use:

The Intended Use of the Pride Mobility T3 Lift Chair is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.

#### Non-Clinical Testing:

The Pride Mobility T3 Lift Chair was tested to the following Safety Standards: CAL 117 Sections A. D. & E - Flammability Testing for Upholstered Furniture BS5852 - Flammability (foam and fabric)

EN 61000-6-3, and EN 61000-6-1 - Electromagnetic Emissions & Immunity Tests EN60601-1 / A2: 1995 / EN60601-1 / A2: 1995 -- Medical Electrical Equipment -General Requirements for Safety

Fatigue Testing - Cycle Tests, Impact Tests, and Downward Force Tests

## Discussion of Clinical Testing Performed:

N/A

#### Conclusions:

The Pride Mobility T3 Lift Chair has the same intended use and similar technological I characteristics as the C5 (K070950), moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the T3 Lift Chair is substantially equivalent to the predicate device, has passed all the necessary testing, and is considered to be safe for user operation.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Pride Mobility Products Corporation % Mr. Thomas Schappert 182 Susquehanna Avenue Exeter, Pennsylvania 18643-2694

DEC - 2 2009

Re: K091578

Trade/Device Name: T3/Electric Positioning Chair Regulation Number: 21 CFR 890.3110 Regulation Name: Electric positioning chair Regulatory Class: Class II Product Code: INO Dated: October 21, 2009 Received: November 2, 2009

Dear Mr. Schappert:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Thomas Schappert

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 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely yours,

Mark M Millman

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

Enclosure

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## Exhibit 3

### Indications for Use

### 510(k) Number (if known): K

#### Device Name: T3 / Electric Positioning Cliair

#### Indications for Use:

The Intended Use of the Pride Mobility T3 I...ift Chair is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.

#### Prescription Use x AND / OR (Part 21 CFR 801 Subpart D)

#### Over-The-Counter Use × (21 CFR 807 Subpart C)

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

Concurrence of GDRH, Office of Device Evaluation (ODE)

FOR M. MELKERSON

(Division Sign-Off)

Division of Surgical. Orthopedic. and Restes alive Devices

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510(k) Number: K011578