← Product Code [IOR](/productcode/IOR) · K021866 # KARMA 800 SERIES MANUAL WHEELCHAIR (K021866) _Vestil Manufacturing Corp. · IOR · Jun 14, 2002 · Physical Medicine · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K021866 ## Device Facts - **Applicant:** Vestil Manufacturing Corp. - **Product Code:** [IOR](/productcode/IOR.md) - **Decision Date:** Jun 14, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.3850 - **Device Class:** Class 1 - **Review Panel:** Physical Medicine ## Indications for Use The intended use of the Karma 800 Series Manual Wheelchair is to provide mobility to persons limited to a sitting position. ## Device Story The Karma 800 Series is a user-propelled, manual mechanical wheelchair designed for indoor mobility. It features a folding aluminum alloy frame with cross braces, large rear wheels with hand rims for propulsion, and smaller front pivoting casters for steering. The device includes adjustable seat-to-floor heights via dual rear axle positions, swing-back armrests, and swing-away footrests. The seat and back are constructed from slung fabric meeting California 117 flame retardancy standards. The wheelchair is operated by the user or an assistant to provide mobility for individuals with limited sitting capacity. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Mechanical manual wheelchair; aluminum alloy frame with welded round tubing; folding design; slung fabric seat/back (California 117 flame retardancy compliant); adjustable rear axle positions; manual propulsion via hand rims; front pivoting casters. ## 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. ## Predicate Devices - Karma Manual Folding Wheelchair ([K950195](/device/K950195.md)) ## 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}------------------------------------------------ -PH2 # JUN 1 4 2002 # 510(k) Summary # Karma 800 Series Manual Wheelchair ## Intended Use The intended use of the Karma 800 Series Manual Wheelchair is to provide mobility to persons limited to a sitting position. #### Technological Description #### Device Description: The Karma 800 Series Manual Wheelchair is a user propelled mechanical wheelchair. Its intended function and use is to provide mobility to persons limited to a sitting position. The product is designed to be a lightweight, everyday wheelchair for both indoor use. It is a folding, or non-rigid type of wheelchair. The product consist primarily of an aluminum allov frame with cross braces, large rear wheels with hand rims for propelling the chair, and smaller front pivoting casters for steering and turning. The frame is constructed of round, aluminum alloy tubing that is welded. The seat-to-floor heights are adjustable via dual rear axle positions. The slung fabric seat and back meets the requirements of California 117 specifications for flame retardancy. Swing back armrest and swing away footrest are standard features. #### Substantial Equivalence The product that is substantially equivalent to the Karma 800 Series Manual Wheelchair is Karma Manual Folding Wheelchair (K950195). Each of these products is a manually operated, manual mechanical wheelchair with the same intended function and use which is to provide mobility to persons limited to a seated position. All products consist basically of an aluminum alloy folding frame with braces to support the wheelchair, large rear wheels, and smaller front pivoting casters for turning and steering. #### Performance Data NA {1}------------------------------------------------ # 510(k) Summary # Vestil Manufacturing Corporation's 510(k) Premarket Notification Karma 800 Series Manual Wheelchair # Submitter's Name, Address, Telephone, Fax Number, and Contact Name Karma Medical Products, Co., LTD. No. 2363 Section 2, Da-Shiue Road Min-Hsiung Shiang Chia-Yi Hsien, 621. Taiwan Phone: 886 5 206 6688 Fax: 886 5 206 7788 ## Manufacturer's Name, Address, Telephone, and Fax Number Same as Above Name of Device Karma 800 Series Manual Wheelchair Name of Applicant/Submission Correspondent, Address, Phone, Fax Number, and Contact Name Vestil Manufacturing Corporation 900 Growth Parkway Angola, IN 46703 Phone 260.668.5677 Fax: 260.668.8967 Rick Michael - rick@vestil.com Date Prepared Mav 2002 Common or Usual Name Manual Wheelchair Classification Wheelchair, Mechanical 89IOR #### Predicate Device The product that is substantially equivalent to the Karma 800 Series Manual Wheelchair is the Karm: Manual Folding Wheelchair (K950195). {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing, ribbon-like shape at the bottom. Public Health Service 'JUN 1 4 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Rick Michael North America Sales Manager Vestil Manufacturing Company 900 Growth Parkway Angola, IN 46703 Re: K021866 Trade Name: Karma 800 Series Regulatory Number: 890.3850 Regulatory Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: June 6, 2002 Received: June 6, 2002 Dear Mr. Michael: 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. {3}------------------------------------------------ # Page 2 -- Mr. Rick Michael 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 and additionally 21 CFR Part 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 device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Mark N Mellheusen Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 510(k) Number (if known): Device Name: KARMA 800 SERIES Indications For Use: THE INTENDED USE OF THE KARMA 800 SERIES MANUAL WHEELCHAIR IS TO PROVIDE MOBILITY TO PERSONS LIMITED TO A SITTING POSITION. FDA/CDRH/ODE/DMC JUN 6 '02 1 35 PM RECEIVED (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) ાન Over-The-Counter Use √ (Optional Format 1-2-96) Mark N. Wilkerson on-()ff) vision of General, Restorative and Neurological Devices 510(k) Number K021866 --- **Source:** [https://fda-staging.innolitics.com/device/K021866](https://fda-staging.innolitics.com/device/K021866) **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