(76 days)
Not Found
No
The device description and summary do not mention any AI or ML capabilities. The testing standards listed are for mechanical and safety performance, not software or algorithmic performance.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is a wheelchair designed to assist mobility for children with walking impediments, which is an assistive device rather than a therapeutic one.
No
Explanation: The device is described as a wheelchair, which is a mobility aid, not a device used to diagnose medical conditions.
No
The device description clearly states it is a "lightweight, adaptive, and multifunctional wheelchair" with a "rigid frame of aluminum" and "nylon upholstery," indicating it is a physical hardware device.
Based on the provided information, the BRAVOracer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for children who are unable to walk or have a walking impediment, providing mobility. This is a physical support function, not a diagnostic one.
- Device Description: The description details a wheelchair with features related to mobility, comfort, and adjustability. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There are no mentions of image processing, AI/ML, input imaging modality, anatomical site for diagnostic purposes, or performance metrics related to diagnostic accuracy (like sensitivity, specificity, AUC).
- Performance Studies: The performance studies listed are related to safety and performance standards for wheelchairs (e.g., EN 12182, EN 12183, ISO 7176 series), not diagnostic performance.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The BRAVOracer does not perform any such function.
N/A
Intended Use / Indications for Use
The BRAVOracer is a lightweight, rigid, high strength aluminum wheelchair for everyday use. This wheelchair provides mobility to physically challenged children. This wheelchair can be moved by the user propelling the hand rims, which are attached to the rear (drive) wheels. This wheelchair can also be pushed by an assistant grasping the pushbar attached to the back rest.
Children who are unable to walk or who have a walking impediment.
Product codes
IOR
Device Description
The BRAVOracer is a lightweight, adaptive, and multifunctional wheelchair. It was designed for children who are unable to walk or who have a walking impediment. This wheelchair can be moved either by the patient him/herself or by another person. The BRAVOracer is a rigid frame of aluminum.Seat height is front and rear adjustable, with various widths and heights. It has a width of 47-66 cm. The seat material is nylon upholstery. All backs are adjustable and all armrests are removable. It has a swing-away footrest with a weight capacity of 60 kg or approximately 132 pounds. Each wheelchair has the following accessories: Anti-Tipper, Transport Wheels, Crutch Holder, Clothing Protector or Side Panels, Drum Brakes, Wheel Lock, Tray, Lap Bclt, Aluminum Footrest, Elevating Footrest, Folding Back, Spoke Protectors, 20-24" Rear Wheels.
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
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)
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
Ko82314
:
OCT 2 8 2008
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information
-
Classification Name:
-
Regulation Number:
-
Product Code:
-
Class:
| 1. | Submitter's Name: | OTTO BOCK Health Care, LP |
|---|---|---|
| 2. | Address: | Two Carlson Parkway North, Suite 100 |
| Minneapolis, Minnesota USA 55447-4467 | ||
| 3. | Telephone: | 651-773-0002 |
| 4. | Contact Person: | William (Bill) Jackson |
| 5. | Date Prepared: | June 28, 2008 |
| 6. | Registration Number: | 2182293 |
| B. Device | ||
| 1. | Name: | BRAVOracer |
| 2. | Trade Name: | BRAVOracer |
| 3. | Common Name: | Manual Wheelchair |
IOR
890.3850
I
Manual Wheelchair
1
C. Identification of Legally Marketed Devices
| 1. Name: | Start Junior |
|---|---|
| 2. K Number: | K073512 |
| 3. Date Cleared: | January 14, 2008 |
D. Description of the Device
The BRAVOracer is a lightweight, adaptive, and multifunctional wheelchair.
It was designed for children who are unable to walk or who have a walking impediment. This wheelchair can be moved either by the patient him/herself or by another person.
The BRAVOracer is a rigid frame of aluminum.Seat height is front and rear adjustable, with various widths and heights. It has a width of 47-66 cm. The seat material is nylon upholstery. All backs are adjustable and all armrests are removable. It has a swing-away footrest with a weight capacity of 60 kg or approximately 132 pounds.
Each wheelchair has the following accessories:
- Anti-Tipper .
- Transport Wheels ♥
- Crutch Holder ●
- Clothing Protector or Side Panels .
- Drum Brakes ●
- Wheel Lock .
- . Tray
- Lap Bclt .
- Aluminum Footrest .
- Elevating Footrest .
- . Folding Back
- Spoke Protectors .
- 20-24" Rear Wheels #
2
E. Intended Use Statement
The BRAVOracer is a lightweight, rigid, high strength aluminum wheelchair for everyday use. This wheelchair provides mobility to physically challenged children. This wheelchair can be moved by the user propelling the hand rims, which are attached to the rear (drive) wheels. This wheelchair can also be pushed by an assistant grasping the pushbar attached to the back rest.
F. Technological Characteristics Summary
The BRAVOracer is substantially equivalent to the Start Junior, cleared on January 14, 2008 as K073512.
The wheelchair is an aluminum frame, rigid, manual, folding wheelchair for everyday usc with an adjustable seat, removable armrests, and adjustable back heights for users of approximately 60kg or 132 lbs.
The Start Junior was tested by Berlin Cert to the following standards:
- . EN 12182
- EN 12183 .
- EN/ISO 10993-5 .
- ISO 7176-1 .
- . ISO 7176-3
- . ISO 7176-5
- � ISO 7176-7
- . ISO 7176-8
- ISO 7176-16 .
- . ANSI/RESNA 7176-19
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 2008
Otto Bock Health Care, LP % Mr. William Jackson 2247 Jennifor Lanc Saint Paul, Minnesota 55109
Re: K082314
Trade/Device Name: BRAVOracer Pediatric Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair. Regulatory Class: Class I Product Code: IOR Dated: June 28, 2008 Received: August 28, 2008
Dear Mr. Jackson:
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 cnclosure) 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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
4
Page 2 - Mr. William Jackson
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): To be determined
Device Name: BRAVOracer Pediatric Manual Wheelchair
Indications for Use:
- . Children who are unable to walk or who have a walking impediment.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number.
Page 1 of 1