(110 days)
To provide an optional means of mobility for physically challenged people.
PHFW-10 Folding Power Chair
The provided text is an FDA 510(k) clearance letter for a powered wheelchair, the PHFW-10 Folding Power Chair. This document does not contain any information about acceptance criteria for a medical device's performance, nor does it describe a study proving the device meets such criteria.
The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than rigorous clinical performance studies with specific acceptance criteria that would typically be associated with AI or diagnostic algorithm submissions.
Therefore, I cannot provide the requested information from the given text. The text does not include details on:
- Acceptance criteria and reported device performance: This document is about regulatory clearance, not performance metrics like sensitivity, specificity, accuracy, or similar measures that would imply acceptance criteria.
- Sample size, data provenance: No study is described, so no sample size or data origin is mentioned.
- Number/qualifications of experts, adjudication method: These pertain to ground truth establishment for a performance study, which is not present.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable here, as it's not an AI or diagnostic device being evaluated in a clinical context in this document.
- Standalone performance study: No such study is mentioned.
- Type of ground truth used: Not applicable.
- Training set sample size: No training data or AI algorithm is discussed.
- Ground truth for training set: Not applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ·
NOV 1 9 2002
Pihsiang Machinery Mfg. Co., Ltd. c/o Mr. Chris Tinsley -President Pillar Technology, Inc. 1101 Illinois Street P. O. Box 187 Neodesha, Kansas 66757
Re: K022539
Trade/Device Name: PHFW-10 Folding Power Chair Regulation Number: 890.3860 Regulation Name: Wheelchair, powered Regulatory Class: Class II Product Code: ITI Dated: October 24, 2002 Received: October 28, 2002
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 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.
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Page 2 -- Mr. Chris Tinsley
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 vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vours,
Mark N Mckesson
Celia M. Witten, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) Number (if known):
Device Name: _PHFW-10 Folding Power Chair
Indications for Use:
To provide an optional means of mobility for physically challenged people.
(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
unter Use /
Mark N. Milker
Number K022539
(Optional Format 1-2-96)
§ 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).