INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3

K030814 · Invacare Corp. · INI · Mar 20, 2003 · Physical Medicine

Device Facts

• Record ID: K030814
• Device Name: INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3
• Applicant: Invacare Corp.
• Product Code: INI · Physical Medicine
• Decision Date: Mar 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Indications for Use

The intended use of the Adventure scooters is to provide mobility to persons limited to a seated position.

Device Story

Motorized 3-wheel scooter for indoor/outdoor transport; provides mobility to users limited to seated position. Components: welded steel frame, transaxle motor drive, braking system, electronic motor controller, adjustable seat, tiller steering, throttle control. Powered by two 12V DC batteries; includes on-board charger. Disassemblable for transport. Diagnostic status LED on control panel flashes to indicate controller/wiring faults; diagnostic feature does not control scooter operation. Operated by user via tiller and throttle. Benefits: provides independent mobility for individuals with limited mobility.

Clinical Evidence

Bench testing only. Device meets requirements of ANSI/RESNA WC/14 (1991) and ISO 7176: 1993 (E) for power and control systems of electric wheelchairs. Upholstery meets California 116 and 117 fire retardancy specifications.

Technological Characteristics

Welded steel frame; 3-wheel configuration; rear-wheel drive; 12V DC battery power; electronic motor controller. Standards: ANSI/RESNA WC/14 (1991), ISO 7176: 1993 (E). Upholstery meets CA 116/117 fire standards. Diagnostic LED indicator for system faults.

Indications for Use

Indicated for persons limited to a seated position requiring mobility assistance. No specific age or gender restrictions noted.

Regulatory Classification

Identification

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

Predicate Devices

• Lynx scooters (K010135)

Reference Devices

• Panther scooters

Submission Summary (Full Text)

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MAR 2 0 2003

K030814

# 510(k) SUMMARY INVACARE CORPORATION'S 510(k) PREMARKET NOTIFICATION ADVENTURE MOTORIZED SCOOTERS

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

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: [phone] Facsimile: [phone]

Contact Person: Rae Ann Farrow Manager, Regulatory Compliance

Date Prepared: March 13, 2003

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

Name of Device: Invacare Adventure Series Scooters

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: [phone] Facsimile: [phone]

## Common or Usual Name

Scooter

#### Classification Name

Motorized Three Wheel Vehicle

#### Predicate Devices

The Adventure Scooters are substantially equivalent to the Lynx scooters (K010135, 2/16/2001).

#### Intended Use

The intended use of the Adventure scooters is to provide mobility to persons limited to a seated position.

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### Technological Characteristics and Substantial Equivalence

### Device Description

The Invacare Adventure Series of Scooters are motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to persons limited to a seated position.

The scooters are basic conventional rear wheel drive, rigid frame vehicles that are battery powered. Various options and accessories are available depending upon user needs and preferences. They consist primarily of a welded steel frame, transaxle motor drive system, braking system, electronic motor controller and an adjustable seat. They also include a tiller handle for steering and a throttle control to engage and disengage the scooter motion in both the forward and reverse The scooters can also be disassembled for ease of transport, are directions. powered by two (2) 12 volt DC batteries, and utilize an on-board charger.

The scooters have a status indicator located on the face of the control panel that provides diagnostic information. The status LED will flash a certain number of times, separated by a pause when a fault is detected in the controller or in the wiring. This feature is for diagnostic information only and does not control the operation of the scooter.

The Adventure SX-3 is a compact version of the scooter with a 250 lb. weight capacity while the Adventure LX-3 scooter is a mid-size version of the scooter with a 350 lb. weight capacity.

#### Substantial Equivalence

Products, which are substantially equivalent to the Invacare Adventure scooters, include the Invacare Lynx SX-3, Lynx LX-3, and Lynx LX-3P06 scooters, which were granted clearance by FDA on February 16, 2001 on 510(k) accession number K010135. Each of these products are motorized, 3-wheel scooters with the same intended function and use of providing mobility to persons limited to a seated position.

While there are minor differences in performance specifications of the scooters, 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, Invacare believes that the Adventure series of scooters are substantially equivalent to legally marketed devices currently in commercial distribution.

#### Performance Data

The Invacare Models Lynx and Panther scooters meet the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993 (E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs. The upholstery materials meet California 116 and 117 specifications for fire retardancy.

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MAR 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Rae Ann Farrow Manager, Regulatory Compliance Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, OH 44036-2125

Re: K030814

Trade/Device Name: Invacare Adventure Series Scooters Regulation Number: 890.38002 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: March 13, 2003 Received: March 14, 2003

Dear Ms. Farrow:

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 - Ms. Rae Ann Farrow

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 yours.

Mark N Millman

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: Invacare Adventure Series Scooters

Indications For Use: To provide mobility to persons limited to a seated position.

Mark N Williamson

Division Signn. Restorative Division of Ge: and Neurologica. Devices

14 " 10(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

**Over-The-Counter Use** √

(Optional Format 1-2-96)