C.T.M. MOBILITY SCOOTER, MODEL HS-310

K070025 · C.T.M. Homecare Product, Inc. · INI · Feb 1, 2007 · Physical Medicine

Device Facts

• Record ID: K070025
• Device Name: C.T.M. MOBILITY SCOOTER, MODEL HS-310
• Applicant: C.T.M. Homecare Product, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Feb 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The C.T.M. Mobility Scooter HS-310 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Device Story

Battery-operated, three-wheeled indoor/outdoor mobility scooter; features padded seat, adjustable armrests, and steering column-mounted hand controls for rider-operated movement; includes on-board battery charger; device is user-operated; provides mobility assistance for disabled or elderly individuals; disassembles for transport.

Clinical Evidence

No clinical data submitted. Performance testing conducted per FDA guidance for motorized three-wheeled vehicles.

Technological Characteristics

Battery-operated; single motor; automatic braking system; three-wheeled base; on-board battery charger; disassemblable frame; indoor/outdoor use.

Indications for Use

Indicated for disabled or elderly persons requiring indoor/outdoor transportation assistance.

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

• C.T.M. Mobility Scooter HS-320 (K012791)

Submission Summary (Full Text)

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K070025

## 510(k) SUMMARY

| Submitter's name: | C.T.M. Homecare Product, Inc.<br>13825 Norton Ave., Chino, CA 91710 | | FEB - 1 2007 |
|---------------------------|---------------------------------------------------------------------------------------------------|--|--------------|
| Contact name and address: | Linda J. Bovard, Bovard Consulting, LLC<br>29611 Simmons Road, Eugene, OR 97405<br>[phone] | | |
| Date summary prepared: | 12/28/06 | | |
| Device name: | C.T.M. Mobile Stretcher, HS-310 | | |

Proprietary name: Common or usual name: Classification name:

C.T.M. Mobility Scooter HS-310 Electric scooter Motorized three-wheeled vehicle (890.3800). Motorized 3-wheeled vehicle (89 INI).

Legally marketed device for substantial equivalence comparison:

The predicate device for this submission is the C.T.M. Mobility Scooter HS-320 submitted by Warepalmy Enterprise LLC (USA) and cleared for marketing under 510(k) "K012791.

Description of the device:

The C.T.M. Mobility Scooter HS-310 is an indoor/outdoor scooter that is battery operated. It has a base with three wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column which allow the rider to control the movement of the scooter. It can be disassembled for transport and has an on-board battery charger.

Intended use of device:

The C.T.M. Mobility Scooter HS-310 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Technological characteristics:

The device features of the C.T.M. Mobility Scooter HS-310 and the HS-320 are very similar. Both are battery operated, have one motor, and have automatic braking systems. On-board battery chargers are provided with both scooters. Both scooters can be disassembled for transport. The target population is identical and the use parameters are similar.

Testing conducted:

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

Performance testing:

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

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C.T.M. Homecare Product, Inc. % Bovard Consulting, LLC Ms. Linda J. Bovard, RAC 29611 Simmons Road Eugene, Oregon 97405

Re: K070025

Trade/Device Name: C.T.M. Mobility Scooter HS-310 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: December 28, 2006 Received: January 3, 2007

-EB 】 2007

Dear Ms. Bovard:

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 - Ms. Linda J. Bovard, RAC

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/industry/support/index.html.

Sincerely you

Fa
Mark N. Mallek

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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C.T.M. Mobility Scooter HS-310 510(k) Notification

## Indications for Use

510(k) Number (if known): __ KO 7002 5

Device Name: C.T.M. Mobility Scooter HS-310

Indications for Use:

The C.T.M. Mobility Scooter HS-310 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Of Division of General, Restorative, and Neurological Devices

**510(k) Number** 10670028