← Product Code [IOR](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR) · K981420 # TC SERIES (WIDE) (K981420) _Get A Life-Give A Living Plus Kids Project, Inc. · IOR · Jun 10, 1998 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K981420 ## Device Facts - **Applicant:** Get A Life-Give A Living Plus Kids Project, Inc. - **Product Code:** [IOR](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR.md) - **Decision Date:** Jun 10, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.3850 - **Device Class:** Class 1 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## Indications for Use These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series (Wide) 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 (Wide) is a manual wheelchair designed for mobility assistance. Device allows for self-propulsion by user or assisted propulsion by caregiver. Used in home, outdoor, hospital, or institutional environments. Provides physical mobility support to patients requiring aid. No electronic or automated components. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Manual wheelchair; mechanical construction. No energy source, software, or electronic components. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 1 0 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 Regulatory 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 aqainst 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 Requlations, Title 21, Parts 800 to 895. ಗಿ 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, {1}------------------------------------------------ ## 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. concerning your devices 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 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please. contact .. the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Collia M. Witton, Ph.D. lia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosures {2}------------------------------------------------ ## Get a Life-Give a Living Plus KiDs Project Inc . 6561 44TH Street North #3010 Pinellas Park, Florida, 33781 Telephone: 813-343-8034 Fax: 813-343-8034 501 (k) Number (if Known): _ _ ( 98) 420 _____________________________________________________________________________________________________________________________________ Device Name:_TC Series (Wide) [Mechanical Wheelchair] Indications for Use: These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series (Wide) 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. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |------------------------------------------|--------------------------------------------------------|-------------------------| | | (Division Sign-Off) | | | 510(k) Number | K981420 | | | Prescription Use
(Per 21 CFR 801.109) | OR | Over- The Counter Use X | | | PAGE 7 | | (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K981420](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K981420) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com