(45 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is for a basic wheelchair.
No
The "Intended Use / Indications for Use" explicitly states, "This device will not diagnose, treat, prevent, cure or polarity and autor chems." This directly contravenes the definition of a therapeutic device.
No
The "Intended Use / Indications for Use" explicitly states, "This device will not diagnose, treat, prevent, oure or pollarity and autor chems."
No
The intended use clearly describes a "wheelchair," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "transport base for pediatric and adult clients" and explicitly says it "will not diagnose, treat, prevent, cure or pollarity and autor chems." IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for transportation.
- Device Description: While the device description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The absence of information in sections like "Mentions image processing," "Mentions AI, DNN, or ML," "Input Imaging Modality," and performance study details further supports that this is not an IVD, as these are often relevant to diagnostic devices.
Therefore, the intended use alone is sufficient to determine that this wheelchair is not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
IOR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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.