(198 days)
The Powerstand Standing Wheelchair in indicated, BY PRESCRIPTION ONLY, for users who have had, or may have in the future, positioning disorders relating to paralysis, paresis or general weakness. The Powerstand Standing Wheelchair helps users with mobility.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Powerstand Stand-up Wheelchair." It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, or AI/algorithm-related details.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study details.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is solely focused on the FDA's determination of substantial equivalence for a physical medical device.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2004
The Standing Company, Inc. Michael A. Olvera 1916 South Niagara Street Suite A Saginaw, Michigan 48602
Rc: K032101
Trade/Device Name: Powerstand Stand-up Wheelchair Regulation Number: 21 CFR 890.3900 Regulation Name: Wheelchair, standup Regulatory Class: II Product Code: IPL Dated: November 13, 2003 Received: December 22, 2003
Dear Mr. Olvera:
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. Michael A. Olvera
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.
Sincerely yours.
Mark A. Millburn
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: K032101
Device Name: Powerstand Standing Wheelchair
Indication for use:
The Powerstand Standing Wheelchair in indicated, BY PRESCRIPTION ONLY, for users who have had, or may have in the future, positioning disorders relating to paralysis, paresis or general weakness. The Powerstand Standing Wheelchair helps users with mobility.
Mark N. Melbers
... of General, Restorative Jeurological Devices
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per21 CFR 801.109)
Over-The Counter Use ___________
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§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).