EASY LIFE

K023521 · Berkline Corp. · INO · Nov 19, 2002 · Physical Medicine

Device Facts

• Record ID: K023521
• Device Name: EASY LIFE
• Applicant: Berkline Corp.
• Product Code: INO · Physical Medicine
• Decision Date: Nov 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Berkline Model Easy Lift Series Lift Out Chair to assist persons who have difficulty rising from a seated position to a standing position.

Device Story

Electrically powered, motor-driven lift chair; assists users in transitioning from seated to standing position. Components include welded steel frame, upholstered chair assembly, and motorized lift actuator. Operated via handheld pendant control. Used in home or extended care environments by elderly or physically challenged individuals. Provides mechanical assistance to improve mobility and independence.

Clinical Evidence

Bench testing only. Device meets UL 1647 (Motor-Operated Massage and Exercise Machines) and UL 73 (Motor Operated Appliances). Upholstery meets California TB 117 flammability standards and UFAC Class I fabric classification.

Technological Characteristics

Electrically powered, motor-driven positioning chair. Construction: welded steel frame, upholstered assembly. Actuation: motorized lift actuator with handheld pendant control. Standards: UL 1647, UL 73, California TB 117, UFAC Class I. No software or electronic algorithms.

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 Health Care Inc. TMR48 Lift Chair (K953342)
• Invacare Model LC Lift Chair (K002171)

Submission Summary (Full Text)

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K023521

NOV 1 9 2002

#### 510(k) SUMMARY

### Berkline Corporation's Model LC Series Lift Out Chairs

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

Berkline Corporation One Berkline Drive Morristown, TN 37813 Phone: [phone] Facsimile: (423) 585- 1760

Contact Person: David Popkin Senior Vice President, Legal services

Date Prepared: September 24, 2002

#### Name of Device and Name/Address of Sponsor

Model Easy Lift Series Lift Out Chairs

Berkline Corporation One Berkline Drive Morristown, Tennessee Phone: [phone] Facsimile: (423) 5856- 1760

#### Common or Usual Name

Lift Out Chair

#### Classification Name

Chair, Electric, Positioning

#### Predicate Devices

Pride Health Care Inc. TMR48 Lift Chair (K953342) and Invacare Model LC Lift Chair (K002171).

#### Intended Use

The intended use of the Berkline Model Easy Lift Out Chair to assist persons who have difficulty rising from a seated position to a standing position.

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## Technological Characteristics and Substantial Equivalence

## A. Device Description

The Berkline Model LC Series Lift Chairs are electrically powered, motor driven devices designed for use in the home or an extended care environment. Their intended function 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 once seated.

The chairs are consist primarily of welded steel frame, an upholstered chair assembly, and motorized lift actuator. A hand held pendant type control is used activate the drive motor and raise or lower the chair to the desired position. Model numbers and physical dimensions vary with the type of aesthetic style of the chair.

### B. Substantial Equivalence

The Berkline Model LC Series Lift Out Chairs are substantially equivalent to Pride Health Care Inc. TMR48 Lift Chair (K953342) and Invacare Corporation Model LC Series Lift Chair (K002171). Each of these products are electrically powered, motor driven, lift out chairs with the same intended function and use which is to assist elderly and/or physically challenged persons to arise from a seated position to a standing position.

## PERFORMANCE DATA

The Berkline Model LC Lift Chairs have been tested to and meet:

- U.L. 1647 "Standard for Motor-Operated Massage and Exercise Machines". ●
- · U.L. 73 "Standard for Motor Operated Appliances"

The upholstery used has been tested to and meets:

- California TB 117 (Flammability) ●
- UFAC Fabric Classification (Class I) .

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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NOV. 1. 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Berkline Corporation David Popkin Senior Vice President, Legal Services One Berkline Drive Morristown, Tennessee 37813

Re: K023521

Trade/Device Name: Easy Life Lift Chair Regulation Number: 890.3110 Regulation Name: Electric positioning chair Regulatory Class: Class II Product Code: INO Dated: October 1. 2002 Received: October 21, 2002

Dear Mr. Popkin:

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. Iisting 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 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.

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Page 2 – Mr. David Popkin

. 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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

for Mark A. Mellema

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

.

Device Name: Berkline LLC Easy Lift Electric Positioning Chair .

·

Indications For Use: The intended use of the Berkline Model Easy Lift Series Lift Out Chair to assist persons, who have difficulty rising from a seated position to a standing position. ficulty rising from a seated position to a standing position. .

:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

for Mark A Milliken
(Division Signer)

(Optional Format 1-2-96)

Dative
a

K023521