(21 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is a standard wheelchair without any indication of advanced computational features.
No.
The device is a wheelchair intended for mobility assistance, not for treating a disease or condition.
No
The device description indicates it is a wheelchair, which is a mobility aid, not a device used to diagnose medical conditions.
No
The device description explicitly states "BRIX wheelchair," which is a physical hardware device, not software.
No, the BRIX wheelchair is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- BRIX Wheelchair Function: The description clearly states the BRIX wheelchair is a device designed to assist children with mobility due to physical impairments. It is a physical aid for movement, not a test performed on biological samples.
The information provided about the BRIX wheelchair describes a medical device used for mobility assistance, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The BRIX 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, stacked on top of each other.
MAY - 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Meyra, Inc. C/o Mr. Kirk L. MacKenzie Official Correspondence Snug Seat, Inc. 12801 East Independence Boulevard Matthews, North Carolina 28106
Re: K050941
Trade/Device Name: BRIX Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: February 28, 2005 Received: April 14, 2005
Dear Mr. MacKenzie:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sured in the encreased of the enactment date of the Medical Device Amendments, or to commerce pror to ritle) 2011-12-11 accordance with the provisions of the Federal Food, Drug, de nees mat have been rout 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 r ou may, increrere, mains 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 your device is etabilied (660 aco re) trols. Existing major regulations affecting your device it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Overning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Dr is issualited your device complies with other requirements of the Act that I Drimas Intactions and regulations administered by other Federal agencies. You must or any I cactar stutures and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It I at 0077, laboring (21 CFR Part 820); and if applicable, the electronic form in the quanty by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Kirk L. MacKenzie
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin maneting your maneling of your device to a legally premarket notification. The PDA Intuing of bassance of the specification 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 If you desire specific advice for your device of variate of the regulation entitled, and of the regulation entitled, Contact the Office of Complance at (210) 276 - 16 - 16 - 16 - 10 - 10 - 10 - 10 - 10 - 16 - 10 - 16 - 16 - 16 - 16 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 6 - - 6 -"Misbranding of relevence to premarket notification of the Act from the Division of Small other general Information on your responsions at its toll-free number (800) 638-2041 or and index by html Manufacturers, International and Oolisanier vilsoww.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Atupt Rworde
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
KOS 0941
510(k) Number:
Device Name:
BRIX
Indications For Use:
The BRIX 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.
AND/OR Prescription Use _ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
x
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styph Curdia
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
KDSD941 510(k) Number_