LLOYD LINDEN, MODEL E04

K071761 · Lloyd Linden, Inc. · IPL · Aug 3, 2007 · Physical Medicine

Device Facts

• Record ID: K071761
• Device Name: LLOYD LINDEN, MODEL E04
• Applicant: Lloyd Linden, Inc.
• Product Code: IPL · Physical Medicine
• Decision Date: Aug 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LLOYD LINDEN EO4 power standup wheelchair is a product which changes people's position from sitting to standing and standing to sitting but also any position in between. It provides indoor and outdoor mobility.

Device Story

Battery-operated power wheelchair; enables user-controlled transition between sitting and standing positions; provides indoor/outdoor mobility. Consists of welded steel frame, transaxle motor drive system, braking system, and electronic motor controller. Powered by two 12V DC batteries with external charger. Operated by user via electronic controller. Facilitates postural changes to assist with daily activities and mobility.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Welded steel frame; transaxle motor drive; electronic motor controller; two 12V DC batteries; battery charger. Indoor/outdoor mobility. Class II device.

Indications for Use

Indicated for individuals requiring assistance transitioning between sitting and standing positions and requiring indoor/outdoor mobility.

Regulatory Classification

Identification

A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.

Predicate Devices

• Lifestand LSC (K061726)

Submission Summary (Full Text)

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K071761

AUG - 3 2007

# Lloyd Linden INC.

No. 10-2, Nei-Chung-Fu, Kan-Chiao Village, Wanli, Taipei County, Taiwan FAX: + 886-2-2492-3113 TEL: [phone]

## 510(k) Summary

#### Device

Trade name: LLOYD LINDEN EO4 power standup wheelchair Common name: Standup wheelchair Classification name: Standup wheelchair Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3900 Product Code: IPL Classification: Class II Predicate devices

Lifestand LSC (K061726) / Lifestand

#### Intend use of device

LLOYD LINDEN EO4 power standup wheelchair is a product which changes people's position from sitting to standing and standing to sitting but also any position in between. It provides indoor and outdoor mobility.

#### Device description:

The LLOYD LINDEN EO4 power standup wheelchair is an indoor/outdoor power stand up wheelchair that is battery operated. The design of this wheelchair is basically similar to other power stand up wheelchairs that are already on the market. It consists primarily of a welded steel frame, transaxle motor drive system, braking system and electronic motor controller and is powered by two 12 volt DC batteries, and utilize a charger.

### Substantial equivalence:

The LLOYD LINDEN EO4 power standup wheelchair is substantially equivalent to the Lifestand LSC (K061726) manufactured by Lifestand.

There are minor differences in performance specifications of the power standup wheelchairs, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, LLOYD LINDEN INC. believes that the LLOYD LINDEN EO4 power standup wheelchair is substantially equivalent to legally marketed devices currently in commercial distribution.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding the top half of the circle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 2007

Lloyd Linden, Inc. % Junnata Chang No. 10-2, Nei-Chung-Fu Kan-Chia Village Wanli, Taipei County Taiwan

Re: K071761

Trade/Device Name: Lloyd Linden E04 Power Standup Wheelchair Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: Class II Product Code: IPL Dated: June 20, 2007 Received: June 29, 2007

Dear Junnata Chang:

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 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 - Junnata Chang

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrl/industry/support/index.html.

> Sincerely you 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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3. Device descriptive information

3.1 Statement of indication for use

### Statement of Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: LLOYD LINDEN EO4 power standup wheelchair

Indications for Use:

The LLOYD LINDEN EO4 power standup wheelchair is a product which changes people's position from sitting to standing and standing to sitting but also any position in between. It provides indoor and outdoor mobility.

| Prescription Use | | Over-The-Counter Use | X |
|-----------------------------|--------|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | AND/OR | (Part 21 CFR 807 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number 1107761

(Posted November 13, 2003)

(Posted November 13, 2003)

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