C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION

K091418 · C.T.M. Homecare Product, Inc. · INI · Jul 6, 2009 · Physical Medicine

Device Facts

• Record ID: K091418
• Device Name: C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION
• Applicant: C.T.M. Homecare Product, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Jul 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The C.T.M. Mobility Scooter HS-628 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Device Story

Battery-operated, three-wheeled motorized scooter; provides indoor/outdoor transportation for disabled or elderly users. Features padded seat, adjustable armrests, and steering column-mounted hand controls for user operation. Includes off-board battery charger. Operates via single motor with automatic braking system. User controls speed and direction directly via hand controls. Benefits include increased mobility and independence for the user.

Clinical Evidence

No clinical data or comparative performance testing submitted. Compliance verified via bench testing per FDA Guidance Document for Powered Wheelchairs and Scooters.

Technological Characteristics

Battery-operated, three-wheeled motorized vehicle. Features single motor, automatic braking system, padded seat, adjustable armrests, and steering column-mounted hand controls. Off-board battery charger included. No software or complex electronic algorithms described.

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-890 (K030387)

Submission Summary (Full Text)

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C.T.M. Mobility Scooter HS-628 510(k) Notification

K091418

JUL - 6 2009

## 510(k) SUMMARY

| Submitter's name: | C.T.M. Homecare Product, Inc. |
|-------------------|----------------------------------------------|
| | 6191 Schaefer Ave., Suite B, Chino, CA 91710 |

Linda J. Bovard, Bovard Consulting, LLC Contact name and address: 29611 Simmons Road, Eugene, OR 97405 [phone]

2/11/09 Date summary prepared:

Device name:

Proprietary name: Common or usual name: Classification name:

C.T.M. Mobility Scooter HS-628 or Orion Electric scooter Motorized three-wheeled vehicle (890.3800). Motorized 3-wheeled vehicle (89 INI).

Legally marketed device for substantial equivalence comparison:

The predicate device is the C.T.M. Mobility Scooter HS-890 submitted by C.T.M. Homecare Product, Inc. and cleared for marketing under 510(k) *K030387.

Description of the device:

The C.T.M. Mobility Scooter HS-628 is an indoor/outdoor scooter that is battery The C.L.M. Hooney Doubler wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column allowing the rider to control the scotter. It is provided with an off-board battery charger.

Intended use of device:

The C.T.M. Mobility Scooter HS-628 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-628 and the HS-890 are very I he uevice features of the or med, have one motor, and have automatic braking systems. similar. Dour are battery operated, sided with both scooters. The target population is identical and the use parameters are similar.

Testing conducted:

Tests listed in the Guidance Document for the Preparation of Premarket Notification I costs Insted in the Gatance Boomical and Scooters, and Motorized Three Wheeled [ 710(k)] Applications for noomarted 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 seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

JUL - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K091418

Trade/Device Name: C.T.M. Mobility Scooter HS-628 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: May 11, 2009 Received: May 13, 2009

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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#### Page 2- Ms. Linda Bovard

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/:

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 yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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C.T.M. Mobility Scooter HS-628 510(k) Notification

# Indications for Use

510(k) Number (if known):

Device Name: C.T.M. Mobility Scooter HS-628

Indications for Use:

The C.T.M. Mobility Scooter HS-628 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K0914/8