EXPLORER POWERED WHEELCHAIR

K023485 · Evermed Corp. · ITI · Dec 2, 2002 · Physical Medicine

Device Facts

• Record ID: K023485
• Device Name: EXPLORER POWERED WHEELCHAIR
• Applicant: Evermed Corp.
• Product Code: ITI · Physical Medicine
• Decision Date: Dec 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Explorer™ Powered Wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position.

Device Story

Explorer™ Powered Wheelchair is a battery-operated indoor/outdoor mobility device. Features tubular metal frame, four wheels, adjustable seat with armrests, and armrest-mounted controller. User operates controller to direct movement. Device is transportable via disassembly; includes battery charger. Intended to provide enhanced mobility for physically challenged individuals. Substantially equivalent to predicate in design, operation, and use parameters.

Clinical Evidence

No clinical data submitted. Performance testing conducted per 1995 FDA Guidance Document for Mechanical and Powered Wheelchairs.

Technological Characteristics

Tubular metal frame; battery-operated; dual-motor drive; automatic braking system; armrest-mounted controller; indoor/outdoor form factor; modular/disassemblable design.

Indications for Use

Indicated for physically challenged persons limited to a sitting position requiring enhanced mobility.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• Regency Power Wheelchair (K001923)

Submission Summary (Full Text)

{0}------------------------------------------------

K023485

DEC 0 2 2002

## 510(k) SUMMARY

Submitter's Name:

EVERMED Corporation 4999 E. La Palma Avenue Anaheim. CA 92807 [phone]

October 16, 2002 Date summary prepared:

Device name:

Proprietary name: Common or usual name: Classification name:

Explorer™ Powered Wheelchair Power chair. Powered wheelchair, Class II, 21 CFR 890.3860.

Legally marketed device for substantial equivalence comparison:

Regency Power Wheelchair submitted by Gendron, Inc. and cleared for marketing under 510(k) "K001923.

Description of the device:

The Explorer™ Powered Wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The product has a metal frame with four wheels, an adjustable seat with armrests, and a controller attached to one armrest. The controller allows the rider to control the movement of the chair. The chair can be disassembled for transport and is provided with a battery charger.

Intended use of device:

The EVERMED Explorer™ Powered Wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position.

Technological characteristics:

The device features and use parameters of the Explorer™ Powered Wheelchair and the Regency Power Wheelchair are very similar. Both have tubular metal frames, are battery operated, have two motors, and have automatic braking systems. Both use the same controller. Battery chargers and instructions for their use are supplied with both chairs. Use parameters are very similar as well, with minor variations in such areas as travel range and maximum speed.

Testing conducted:

Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the subject 510(k) submission.

Performance testing:

Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).

{1}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles or faces in a row, connected by flowing lines.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 02 2002

Evermed Corporation R.S. McQuate & Associates, Inc. c/o Robert S. McQuate 3636 E. Columbine Drive Phoenix, Arizona 85032

Re: K023485

Trade/Device Name: Explorer™ Powered Wheelchair Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: October 16. 2002 Received: October 17, 2002

Dear Mr. McQuate:

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

{2}------------------------------------------------

Page 2 - Mr. Robert S. McQuate

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. 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]. 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" (21CFR 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,

Miriam C. Provost

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

Enclosure

{3}------------------------------------------------

Explorer™ Powered Wheelchair 510(k) Notification Page 3

## Indications for Use Statement

510(k) Number ( if known): _ K O2 34 85

Device name: Explorer™ Powered Wheelchair

Indications for Use: The Explorer™ Powered Wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position.

> (Please do not write below this line) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Muriam C. Provost

K 623485