(89 days)
To provide an optional means of mobility for physically challenged people.
Not Found
This document is a 510(k) clearance letter for the "Zippy" powered wheelchair. It is a regulatory document and does not contain information about acceptance criteria or a study proving device performance as it would be presented for an AI/ML-based medical device.
Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document. The document primarily focuses on:
- Regulatory Clearance: Affirming that the device meets the substantial equivalence requirements for market entry.
- Device Classification: Assigning a regulatory class (Class II) and product code (ITI).
- General Controls: Reminding the manufacturer of ongoing regulatory responsibilities.
- Indications for Use: Stating the intended purpose of the device (to provide an optional means of mobility for physically challenged people).
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pihsiang Machinery Manufacturing Co., Ltd. C/o Mr. Chris Tinsley President Pillar Technology, Inc. P. O. Box 187 1101 Illinois Street Neodesha, Kansas 66757
NOV 2 0 2001
Re: K012846
Trade/Device Name: Zippy Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: August 17, 2001 Received: August 23, 2001
Dear Mr. Tinsley:
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 10 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
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Page 2 - Mr. Chris Tinsley
(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.
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,
Sincerely yours,
Mark N Milliken
Celia M. Witten, Ph.D., M.D. Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND D.O. d/t:HFZ-410:EXEinberg:bxw:11/7/01
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NOV 2 0 2001
KOIS 510(k) Number (if known): 246
ZIPPY Device Name:
To provide an optional means of mobility for physically Indications For Use: challenged people.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A Melkus
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K01.2846
escription Use (Pcr 21 CFR 801.109)
Over-The-Counter Use
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).