(147 days)
No
The description focuses on standard powered wheelchair components and safety features, with no mention of AI or ML capabilities.
No
The device is a powered wheelchair designed for mobility, not to treat or cure any medical condition.
No
The device is described as a powered wheelchair intended to provide mobility. There is no mention of it being used to diagnose conditions, process images for diagnosis, or provide any diagnostic insights.
No
The device description clearly outlines a physical powered wheelchair with hardware components such as a frame, motors, batteries, and wheels. While it has a "digital controller," the primary function and components are hardware-based.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to individuals with limited mobility. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a powered wheelchair with components related to mobility (motors, batteries, frame, etc.). It does not involve analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
This device is clearly a mobility aid, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Pride Mobility Products Corporation device is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.
Product codes
ITI
Device Description
The Jazzy Elite 6 is a Powered Wheelchair having a digital controller, electrical system, motors, batteries, seating, and frame. The Jazzy Elite 6 is equipped with electronic regenerative disc brakes, 3A off-board battery charger, removable 12 volt batteries, drive wheels, and front and rear caster wheels.
The Jazzy Elite 6 is designed with ultimate safety, stability, and performance in mind. The Powered Wheelchair is designed for, but not limited to Pride Mobility Products Corporation, providers/retailers and their consumers.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Compliance to applicable Testing Standards is as follows (See 7F for FDA-3654 forms):
RESNA WC Vol.1 2009 - Requirements and Test Methods for Wheelchairs (Including Scooters)
RESNA WC Vol. 2 2009 - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems
ANSI/RESNA WC Vol. 2-2008 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.
CAL 117 - Flammability Testing
ISO 10993 -Biocompatibility Testing
Clinical Testing Performed: N/A
Conclusions:
The Jazzy Elite 6 Powered Wheelchair has the same intended use and similar technological characteristics as the Jazzy Frontie (K092961), 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 Jazzy Elite 6 is substantially equivalent to the predicate device, has passed all the necessary testing, and is considered to be safe for user operation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, italicized font, with a registered trademark symbol next to the "e". Below the word "Pride" is the text "Mobility Products Corp." in a smaller, non-italicized font.
APR 1 8 2012
AGE 10 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990
KII3489
Exhibit 1 510(k) Summary Pride Mobility Products Corporation Jazzv Elite 6
Submitter's Name & Address:
Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, Pa. 18643 Phone: (570) 655-5574 Facsimile: (570) 655-1470
Contact Person:
Kimberly Blake
Date Prepared: 11/18/2011
Name of Device and Proprietary Name: Jazzy Elite 6
Common or Usual Name: Powered Wheelchair
Classification Name:
Physical Medicine / Powered Wheelchair
Product Code:
ITI
Comparison to Predicate Devices:
The Jazzy Elite 6 is substantially equivalent to the Pride Mobility Jazzy Frontie (K092961), when comparing performance, maneuverability, stability, and structure, The performance characteristics and the position of the electronics and drive mechanisms are similar to achieve the same intended use function that enables the user to maintain optimum stability without hindering performance. Refer to Exhibit 7 for verification and validation activities.
The major differences between the Jazzy Elite 6 and the Jazzy Frontie (K092961) are in the front wheels. The Jazzy Frontie (K092961) has four (4) wheels on the ground while the Jazzy Elite 6 has six (6) wheels on the ground:
- Jazzy Frontie (K092961) utilizes 3" front anti-tip wheels (off of the ground) . versus the Jazzy Elite 6 which utilizes 5" front caster wheels (on the ground).
1
Image /page/1/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, sans-serif font, with the "i" dotted with a registered trademark symbol. Below "Pride" is the text "Mobility Products Corp." in a smaller, sans-serif font. The logo is black and white.
KIT3488 AGE 2 OF 2 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990
Device Description:
The Jazzy Elite 6 is a Powered Wheelchair having a digital controller, electrical system, motors, batteries, seating, and frame. The Jazzy Elite 6 is equipped with electronic regenerative disc brakes, 3A off-board battery charger, removable 12 volt batteries, drive wheels, and front and rear caster wheels.
The Jazzy Elite 6 is designed with ultimate safety, stability, and performance in mind. The Powered Wheelchair is designed for, but not limited to Pride Mobility Products Corporation, providers/retailers and their consumers.
Intended Use:
The intended use of the Pride Mobility Products Corporation device is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.
Non-Clinical Testing:
Compliance to applicable Testing Standards is as follows (See 7F for FDA-3654 forms): RESNA WC Vol.1 2009 - Requirements and Test Methods for Wheelchairs (Including Scooters) RESNA WC Vol. 2 2009 - Additional Requirements for Wheelchairs (Including Scooters)
with Electrical Systems ANSI/RESNA WC Vol. 2-2008 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.
CAL 117 - Flammability Testing
ISO 10993 -Biocompatibility Testing
Discussion of Clinical Testing Performed:
N/A
Conclusions:
The Jazzy Elite 6 Powered Wheelchair has the same intended use and similar technological characteristics as the Jazzy Frontie (K092961), 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 Jazzy Elite 6 is substantially equivalent to the predicate device, has passed all the necessary testing, and is considered to be safe for user operation.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 8 2012
Pride Mobility Product Corporation % Ms. Kimberly Blake Assistant Manger, Regulatory QA-Regulatory Compliance 182 Susquehanna Avenue Exeter. Pennsylvania 18643
Re: K113488
Trade/Device Name: Jazzy Elite 6 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 19, 2012 Received: March 19, 2012
Dear Ms. Blake:
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 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) 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
3
Page 2 - Ms. Kimberly Blake
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eunel Keith
´Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, sans-serif font, with the letters slightly overlapping. Below "Pride" is the text "Mobility Products Corp." in a smaller, sans-serif font. The logo is black and white.
..
182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990
Exhibit 3
Indications for Use
510(k) Number (if known): K
Device Name: Jazzy Elite 6
Indications for Use: The intended use of the Pride Mobility Products Corporation device is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND / OR
Over-The-Counter Use × (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Div) Rick -Off Sigh Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113488