TC SERIES

K981422 · Get A Life-Give A Living Plus Kids Project, Inc. · IOR · Jun 10, 1998 · Physical Medicine

Device Facts

• Record ID: K981422
• Device Name: TC SERIES
• Applicant: Get A Life-Give A Living Plus Kids Project, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Jun 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series are for self-propelling or to be propelled by a care giver. These wheelchairs can be use for everyday in the home or outdoors, hospitals, or institution.

Device Story

TC Series manual wheelchairs provide mobility assistance to individuals requiring support. Operated by user (self-propelling) or caregiver; used in home, outdoor, hospital, or institutional environments. Device functions as a mechanical transport aid; no electronic or software components. Provides patient mobility and independence.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual wheelchair; mechanical construction; no energy source; no software; no electronic components.

Indications for Use

Indicated for persons requiring mobility assistance. Suitable for self-propulsion or caregiver-assisted propulsion. Intended for daily use in home, outdoor, hospital, or institutional settings.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 10 1998

Mr. Eugene M. Naves President/CEO Get a Life-Give a Living Plus KiDs Project, Inc. 6561 44th Street North #3010 Pinellas Park, Florida 33781

Re: K981418 TC Series (Transport) K981419 TC Series (Tilt Recliner) K981420 TC Series (Wide) K981421 TC Series (Recliner) K981422 TC Series Requlatory Class: I Product Code: IOR Dated: April 18, 1998 Received: April 20, 1998

Dear Mr. Naves:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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,

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## Page 2 - Mr. Eugene M. Naves

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 In addition, FDA may publish further announcements action. Please note: concerning your devices in the Federal Register. 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 devices as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

Collia M. Witton, Ph.D.

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

Enclosures

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## Get a Life-Give a Living Plus KiDs Project Inc . 6561 44TH Street North #3010

Pinellas Park, Florida, 33781 Telephone: [phone] Fax: [phone]

501 (k) Number (if Known): `K981422

Device Name: TC Series [Mechanical Wheelchair]

Indications for Use:

These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series are for self-propelling or to be propelled by a care giver. These wheelchairs can be use for everyday in the home or outdoors, hospitals, or institution.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------|---------|
| of General Restorative Devices | K981422 |
| er. | |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over- The Counter Use X |
|------------------------------------------|----|-------------------------|
|------------------------------------------|----|-------------------------|

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