(121 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description suggests a mobility aid without complex data processing.
No
The device, "Coach 888W," is described as providing "an optional means of mobility for physically challenged people," which indicates it is an assistive device for mobility, not a therapeutic device. Therapeutic devices are typically used for treatment, diagnosis, or prevention of disease.
No
Explanation: The intended use of the device is to provide an optional means of mobility for physically challenged people, which is a functional aid, not a diagnostic purpose.
Unknown
The provided 510(k) summary lacks sufficient detail about the device's components and functionality to definitively determine if it is software-only. It only provides a name and intended use, with no information about hardware or software aspects.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To provide an optional means of mobility for physically challenged people." This describes a device used on a person for a physical function (mobility), not a device used to examine specimens from the body (like blood, urine, or tissue) to diagnose or monitor a medical condition.
- Lack of IVD Indicators: The description lacks any mention of:
- Analyzing biological specimens.
- Diagnosing, monitoring, or treating a disease or condition based on specimen analysis.
- Any of the typical components or processes associated with IVDs (reagents, assays, specimen handling, etc.).
Therefore, the Coach 888W, as described, falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To provide an optional means of mobility for physically challenged people.
Product codes
ITI
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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a symbol consisting of three stylized lines that resemble a person with outstretched arms. The seal is black and white and appears to be a logo or emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 2003
Mr. Chris Tinsley Wheelchair & Scooter Express L.C. 4905-A San Jacinto Houston, TX 77004
Re: K030760
Trade/Device Name: Coach 888W Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: February 26, 2003 Received: June 20, 2003
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), 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 yours,
Miriam C. Provost
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
510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: Coach 888W
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 v
Muriam C. Provost
Division Sion-Off Division of General, Restorative and Neurological Devices
(Optional Format 1-2-96)
K030760 510(k) Number ________________________________________________________________________________________________________________________________________________________________