(45 days)
This wheelchair is designed as a transport base for pediatric and adult clients. This device will not diagnose, treat, prevent, oure or pollarity and autor chems. I hus devi users users.
Not Found
This is a 510k clearance letter for a medical device called "Tri Pod", a mechanical wheelchair. The letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it does not require a new premarket approval (PMA) application.
However, the provided document does not contain any information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or study methodologies.
Therefore, I cannot answer your specific questions as the relevant data is not present in the provided text. The document is solely an FDA clearance letter and does not include technical specifications or study details.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal for the Department of Health and Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three overlapping human profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2006
Freedom Designs, Inc. % Mr. Bob Gardner General Manager 2241 Madera Road Simi Valley, California 93065
Re: K060926
Trade/Device Name: Tri Pod Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: April 18, 2006 Received: April 21, 2006
Dear Mr. Gardner:
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
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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), please contact the Office of Compliance at (240) 276-0120. 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 yours,
Hubert Lumer no
C Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K060926
Device Name: Tri Pod
Indications For Use:
This wheelchair is designed as a transport base for pediatric and adult clients. This device will not diagnose, treat, prevent, oure or pollarity and autor chems. I hus devi
users users.
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-CounterUse (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulb Semer
(Division Sign-Off Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number.
§ 890.3850 Mechanical wheelchair.
(a)
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.(b)
Classification. Class I (general controls).