(148 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the device's intended use for mobility assistance.
No
The device, a wheelchair, provides mobility assistance for children with physical impairments. It does not actively treat or alleviate a medical condition, but rather aids in daily living.
No
Explanation: The device is a wheelchair designed to assist children with mobility needs due to physical impairments, which is an assistive device, not a diagnostic one.
No
The description clearly identifies the device as a "Cheetah Wheelchair," which is a physical mobility device and not software.
Based on the provided information, the Cheetah Wheelchair is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist children with physical impairments with their mobility. This is a physical aid, not a diagnostic test performed on biological samples.
- Device Description: While the description is "Not Found," the intended use clearly points to a physical device for mobility.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
The Cheetah Wheelchair is a medical device, but it falls under the category of a mobility aid, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cheetah Wheelchair is designed for children who have physical impairments that require the use of a device to assist them with their mobility needs. This device is intended solely for pediatric use.
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
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three birds in flight, arranged in a stacked formation. The birds are silhouetted and appear to be soaring upwards.
Public Health Service
MAR 2 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
R82 A/S C/o Kirk L. MacKenzie President Snug Seat, Inc. 12801 East Independence Boulevard Stallings, North Carolina 28105
Re: K033460
Trade/Device Name: Cheetah Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: March 16, 2004 Received: March 16, 2004
Dear Mr. MacKenzie:
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 - Kirk L. MacKenzie
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.
Mark A. Millerson
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
2
INDICATIONS FOR USE
510(k) Number: K033460
CHEETAH WHEELCHAIR Device Name:
The Cheetah Wheelchair is designed for children who have Indications For Use: physical impairments that require the use of a device to assist them with their mobility needs. This device is intended solely for pediatric use.
Aril
(Signature of Certifier)
Tobias Moeller (Typed Name)
15-12-63
(Dated)
| Prescription Use | AND/OR | Over-The-Counter Use | X |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K033460 |
|---|---|
| --------------- | --------- |
SK31
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