(17 days)
Not Found
No
The description focuses on standard powered wheelchair components and performance testing, with no mention of AI or ML.
No.
The device provides mobility to individuals in a seated position but does not actively treat or alleviate a medical condition; it functionally assists rather than therapeutically intervenes.
No
The device description and intended use clearly state that the Quantum Blast is a powered wheelchair designed to provide mobility. There is no mention of it being used to diagnose any medical condition.
No
The device description clearly states it is a battery-powered, motor-driven device with a welded steel base, batteries, and a joystick, indicating it is a physical hardware device, not software-only.
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 mobility to persons limited to a seated position. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a powered wheelchair, its components (batteries, motor, joystick, controller, seat), and construction. None of these are related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device is clearly a medical device designed for mobility assistance, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use of the Quantum Blast is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Product codes
ITI
Device Description
The Pride Quantum Blast model rear-wheeled drive powered wheelchairs are battery powered, motor driven devices. A P&G Remote Plus joystick and 100 amp controller is used to operate the Quantum Blast. The Quantum Blast is powered by two 12 VDC, Group 24 batteries and has a range of up to 25 miles on a full charge. The base of the chair is made of welded steel construction. The Quantum Blast comes standard with a Versa Seat. Optional seating material meets California 117 standards for fire retardancy.
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
Discussion of non-clinical tests performed for determinations of substantial equivalence are as follows: ANSI/RESNA WC/01 1990 Determination of Static Stability Testing ANSI/RESNA WC/02 1991 Determination of Dynamic Stability Testing ANSI/RESNA WC/03 1990 Determination of the Effectiveness of brakes ANSI/RESNA WC/05 1990 Determination of overall Dimensions, Mass, and Turning Space ANSI/RESNA WC/10 1990 Determination of Obstacle Climbing Ability ANSI/RESNA WC/Vol. 2-1998 Requirements and Test Methods for Electromagnetic Compatibility of Electric Powered Wheelchairs and Scooters.
Discussion of Clinical Tests Performed: N/A
Key Metrics
Not Found
Predicate Device(s)
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
JUL 1 3 2001
Exhibit 3
510 (K) Summary : Pride Mobility Products, Inc. 510 (K) Premarket Notification Quantum Blast
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Pride Mobility Products, Inc. 182 Susquehanna Avenue Exeter, Pa. 18643 Phone: (570) 655-5574 Facsimile: (570) 883-4102
Contact Person: Gene Kulon Official Correspondent Date Prepared: 05-16-01
Name of Device and Name / Address of Sponsor:
Quantum Blast
Pride Mobility Products, Inc. 182 Susquehanna Avenue Exeter, Pa. 18643 Phone: (570) 655-5574 Facsimile: (570) 883-4102
Common or Usual Name: Four Wheel Power Base Unit
Classification Name: Power Wheel Chair
Comparison to Predicate Devices:
The product, which is substantially equivalent to the Quantum Blast, is the SC900 (Jazzy) (K945936) they both are Joystick controlled, with onboard batteries and battery charger. All safety features are equivalent.
Device Description:
The Pride Quantum Blast model rear-wheeled drive powered wheelchairs are battery powered, motor driven devices. A P&G Remote Plus joystick and 100 amp controller is used to operate the Quantum Blast. The Quantum Blast is powered by two 12 VDC, Group 24 batteries and has a range of up to 25 miles on a full charge. The base of the chair is made of welded steel
1
construction. The Quantum Blast comes standard with a Versa Seat. Optional seating material meets California 117 standards for fire retardancy.
Intended Use:
The intended use of the Quantum Blast is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Discussion of non-clinical tests performed for determinations of substantial equivalence are as follows:
ANSI/RESNA WC/01 1990 Determination of Static Stability Testing ANSI/RESNA WC/02 1991 Determination of Dynamic Stability Testing ANSI/RESNA WC/03 1990 Determination of the Effectiveness of brakes ANSI/RESNA WC/05 1990 Determination of overall Dimensions, Mass, and Turning Space ANSI/RESNA WC/10 1990 Determination of Obstacle Climbing Ability ANSI/RESNA WC/Vol. 2-1998 Requirements and Test Methods for Electromagnetic Compatibility of Electric Powered Wheelchairs and Scooters.
Discussion of Clinical Tests Performed:
N/A
Conclusions:
The Quantum Blast has the same intended use and similar technological characteristics as the Jazzy SC-900. Moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Quantum Blast device is substantially equivalent to the predicate device. All software used on the Quantum Blast is Y2K Compliant.
Discussion of Clinical Tests Performed:
N/A
2
Image /page/2/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 three human profiles facing to the right, representing the department's focus on health and human well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2001
Mr. Gene R. Kulon Regulatory Compliance Officer Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, Pennsylvania 18643
Re: K011993
Trade/Device Name: Quantum Blast, Powered Wheelchair Regulation Number: 890.3860 Regulatory Class: II Product Code: ITI Dated: June 22, 2001 Received: June 26, 2001
Dear Mr. Kulon:
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 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). 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 (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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 action. In addition, FDA may publish further announcements 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.
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Page 2 - Mr. Gene R. Kulon
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 contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Hyk Rhodes
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
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EXHIBIT 2
Page _ 1 of 1
510(k) Number (if known): K- O / / 9 93
Quantum Blast, Powered Wheelchair Device Name:
Indications for Use:
The intended use of the Quantum Blast is to provide mobility for persons limited to a seated position that are capable of operating a powered wheelchair.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hyet Riode
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011993
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96) *