(28 days)
Not Found
Not Found
No
The summary describes a manual folding wheelchair and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The "Intended Use / Indications for Use" explicitly states, "This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users," which directly contradicts the definition of a therapeutic device.
No
The "Intended Use / Indications for Use" section explicitly states, "This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users."
No
The device description explicitly states it is a "Manual Folding Mobility Wheelchair," which is a physical hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "transport base for pediatric and adult clients" and explicitly says it "will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users." IVDs are used to diagnose, monitor, or screen for diseases or conditions using samples from the human body.
- Device Description: The device is described as a "Manual Folding Mobility Wheelchair," which is a physical mobility aid, not a diagnostic tool.
- Lack of IVD characteristics: The description lacks any mention of analyzing biological samples, chemical reactions, or any other processes typically associated with in vitro diagnostics.
Therefore, this device falls outside the definition of an In Vitro Diagnostic.
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, cure or mitigate any of the population of its' intended 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
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
§ 890.3850 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 seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 1998
Ms. Ginny S. Maloco President Freedom Designs, Inc. 2241 Madera Road 93065 Simi Valley, California
K983763 Re: Manual Folding Mobility Wheelchair Regulatory Class: I Product Code: IOR October 22, 1998 Dated: Received: October 26, 1998
Dear Ms. Maloco:
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 able beated in the 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 requlations.
1
This letter will allow you to begin marketing your device as Inis iccel will assock) premarket notification. The FDA described in jour in jour device of your device to a legally rinding of bubbeansation results in a classification for your marketca predice actes 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 rogardiagnostic devices), please contact the Office of victo diagnobere at (301) 594-4659. Additionally, for questions on comprimee at (oor) advertising of your device, please contact che Dffice 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 Information on John of Small Manufacturers Assistance obtained from the brission (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., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 0
510(k) Number (if known): __x983763
Device Name:_spectrum_Spirit_Manual Folding Mobility Wheelchair Indications For Use:
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
This wheelchair is designed as a transport base for pediatric This device will not diagnose, treat, and adult clients. prevent, cure or mitigate any of the population of its' i intended users.
:
(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
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983763