(54 days)
Not Found
There are no Reference Devices listed in the provided text.
No
The summary describes a standard wheelchair for mobility assistance and contains no mention of AI, ML, or related technologies.
No
The device, a wheelchair, is described as assisting with mobility needs, which is supportive rather than therapeutic.
No
Explanation: The Panther Wheelchair is described as a device to assist with mobility needs, not to diagnose medical conditions.
No
The device description clearly states "Panther Wheelchair," which is a physical mobility device and not software.
Based on the provided information, the Panther Wheelchair is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to assist with mobility for individuals with physical impairments. This is a mechanical function, not a diagnostic one.
- Device Description: It's described as a wheelchair, which is a mobility aid.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a disease, condition, or state of health
- Using reagents or other in vitro methods
Therefore, the Panther Wheelchair falls under the category of a medical device, but specifically a mobility aid, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Panther Wheelchair is designed for children and/or small adults who have physical impairments that require the use of a device to assist them with their mobility needs.
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
children and/or small adults
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1098 OCT
Mr. Kirk MacKenzie President Snug Seat, Inc. 12801 East Independence Boulevard Stallings, North Carolina 28105
Re : K982849 Trade Name: Panther Wheelchair Regulatory Class: I Product Code: IOR Dated: August 10, 1998 Received: August 12, 1998
Dear Mr. MacKenzie:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Kirk MacKenzie
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please croniact. the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.
Celia M. Witten, Ph.D., M.D. Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
STATEMENT OF INDICATIONS FOR USE
The Panther Wheelchair is designed for children and/or small adults who have physical impairments that require the use of a device to assist them with their mobility needs.
Over-the-Counter Use X
ly
(Division Division of General Rest 510(k) Numb