TMC-EASY-302

K984565 · Tmc Magnetics & Machinery Corp. · INI · Feb 16, 2000 · Physical Medicine

Device Facts

• Record ID: K984565
• Device Name: TMC-EASY-302
• Applicant: Tmc Magnetics & Machinery Corp.
• Product Code: INI · Physical Medicine
• Decision Date: Feb 16, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Indications for Use

TMC-Easy-302 is intended for use to transport person outside usually by disabled persons. The scooter has a seated position for carrying person in the considerations of ergonomically.

Device Story

TMC-Easy-302 is a motorized three-wheeled scooter designed for outdoor transportation of disabled individuals. Device features a seated, ergonomic design to support user during transit. Operated by user via onboard controls; powered by battery system with approximately 20-mile range per charge. Intended for personal mobility assistance; helps users navigate outdoor environments. No complex software or algorithmic processing involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized three-wheeled scooter; battery-powered; ergonomic seated configuration; outdoor mobility design.

Indications for Use

Indicated for use by disabled persons for outdoor transportation. Provides seated, ergonomic mobility.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 6 2000

TMC Magnetics & Machinery Corporation C/o Ms. Susan D. Goldstein-Falk MDI Consultants 55 Northern Boulevard Great Neck, New York 11021

Re: K984565

Trade Name: TMC Easy-302 Motorized Three-Wheeled Scooter Regulatory Class: II Product Code: INI Dated: February 8, 2000 Received: February 10, 2000

Dear Ms. Goldstein-Falk:

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 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 (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. A 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. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal 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.

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.

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Page 2 -- Ms. Susan D. Goldstein-Falk

If you desire specific advice for your device on our labeling regulation (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 the Office of Compliance at [phone]. Also, please note 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.

Mark N. Millman

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for use

510(k) NUMBER (IF KNOW): _____________________________________________________________________________________________________________________________________________________

DEVICE NAME: TMC-Easy-302 MOTORIZED THREE-WHEELED SCOOTER INDICATION FOR USE:

TMC-Easy-302 is intended for use to transport person outside usually by disabled persons. The scooter has a seated position for carrying person in the considerations of ergonomically.

The scooter's range on a standard charge varies according to temperature and battery condition, but the average range is approximately 20 miles.

(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)

Mark-N-Mullins

fion

(Division Sign-Off) Division of General Restorative Devices 510(k) Number