ACTIVA

K991132 · Hoveround Corp. · INI · Oct 20, 1999 · Physical Medicine

Device Facts

• Record ID: K991132
• Device Name: ACTIVA
• Applicant: Hoveround Corp.
• Product Code: INI · Physical Medicine
• Decision Date: Oct 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

TO PROVIDE FOR THE CONSUMING POBLIC, SELF-CONTAINED, COMPACT PERSONAL MOBILITY VEHICLE FOR PERSONS WHO ARE UNABLE TO AMBULATE EITHER BECAUSE OF MEDICAL NECESSITY OR THROUGH PERSONAL PERSONAL PREFERENCE VEHICLE IS OPERABLE BOTH INDOORS AND OU 198 THE FOR OUTDOOR USAGE. PRIMARILY INTENDED

Device Story

Motorized 3-wheeled scooter; battery-operated via two rechargeable lead-acid batteries. Features platform connecting three wheels (one front, two rear), adjustable tiller, and operator seat. Operator controls speed and steering via hand controls on tiller. Maximum weight capacity 300 lbs. Includes battery charger. Used by patients for personal mobility in indoor and outdoor environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized 3-wheeled scooter; battery-powered (two rechargeable lead-acid batteries); hand-controlled tiller steering; 300 lb weight capacity; Class II device (Product Code INI).

Indications for Use

Indicated for individuals unable to ambulate due to medical necessity or personal preference requiring a personal mobility vehicle for indoor and outdoor use.

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

• Legend 3 wheeled scooter (K915659)

Submission Summary (Full Text)

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OCT 20 1999

## 510K_Summary of Substantial Equivalence

K99//32

Submitted by

Mr. Thomas E. Kruse, President Hoveround Corporation, 2151 Whitfield Industrial Way, Sarasota, FL. 34243 (941) 739 - 6200 Tel. (941) 727 - 8686 Fax.

Contact person

Stan Cooper

March 29th 1999 Date of Submission

Name of the Device Activa 3 Wheeled Scooter.

Scooter, powered, three wheeled Usual Name

Vehicle, Motorized, 3 Wheeled, Class 11 Classification Name

Regulation number 890.3800

Committee Physical Medicine

INI

Product Code

Device Claimed to be "Legend" 3 wheeled scooter. Substantially Equivalent Pride Healthcare Manufacturer

510K Number K915659

Issue Date 01 - 21 - 92

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# Summary Description of Device.

K991132

The Hoveround Activa is a motorized three wheeled scooter. It is battery operated from two rechargeable lead-acid batteries. It consists of a platform which connects the three wheels, ( one at the center front, one each on the rear left and right sides ), an adjustable tiller and a seat for the operator.

The device can carry a sole seated operator of maximum weight 300 LB and is driven by using hand controls located at the top of the tiller also acting to steer the vehicle.

A battery charger is provided with each model to replenish batteries.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 20 1999

Mr. Stan Cooper Hoveround Corporation 2151 Whitfield Industrial Way Sarasota, Florida 34243

K991132 Re: Trade Name: Activa Regulatory Class: II Product Code: INI Dated: July 22, 1999 Received: July 23, 1999

Dear Mr. Cooper:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. T Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Féderal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Mr. Stan Cooper

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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 Also, please note the Office of Compliance at [phone]. the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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510(k) Number (if known): __ K991132 ·

Device Name: ACTIVA_

Indications For Use. To PROVIDE FOR THE CONSUMING POBLIC, SELF-CONTAINED, COMPACT PERSONAL MOBILITY VEHICLE FOR PERSONS WHO ARE UNABLE TO AMBULATE EITHER BECAUSE OF MEDICAL NECESSITY OR THROUGH PERSONAL PERSONAL PREFERENCE VEHICLE IS OPERABLE BOTH INDOORS AND OU લુકા 198 THE FOR OUTDOOR USAGE. PRIMARILY INTENDED ਉਹਪ

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sigh-Off)
Division of General Restorative Devices K991132
510(k) Number***_***_

Prescription Use (Per 21 CFR 801.109) OR

(Optional Formal 1-2-96)

Over-The-Counter Use