(28 days)
Not Found
No
The description details a standard powered wheelchair with a digital controller and electrical components, but there is no mention of AI or ML capabilities. The performance studies focus on compliance with safety and performance standards for wheelchairs, not on algorithmic performance.
No
A therapeutic device is one that treats or prevents a disease or condition. This device, a powered wheelchair, provides mobility but does not treat or prevent a medical condition.
No
The device is a powered wheelchair designed to provide mobility for disabled persons, not to diagnose medical conditions.
No
The device description explicitly lists hardware components such as motors, batteries, seating, frame, brakes, and wheels, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to disabled persons with limited walking capabilities. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a powered wheelchair with mechanical and electrical components for movement and control. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or treatment based on sample analysis
- Reagents, assays, or laboratory procedures
The Jazzy Frontie is a mobility aid, a type of medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Pride Mobility Products Corp. Jazzy Frontie is to provide mobility to disabled persons having limited walking capabilities.
The intended use of the Pride Mobility Products Corporation Jazzy Frontie is to The intendou aso of those to a seated position that have the capability of operating a Powered Wheelchair.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The Jazzy Frontie is a Powered Wheelchair having a digital controller, electrical 140 outly motors, batteries, seating, and frame. The Jazzy Frontie is equipped with electronic, regenerative disc brakes, off-board battery charger, removable 12 Volt U1 batteries, front anti-tip wheels, and rear caster wheels.
The Jazzy Frontie has a depth adjustable fold flat seat that provides fast, simple adjustment for enhanced, personalized comfort that is removable.
The Jazzy Frontie 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
N/A
Description of the test set, sample size, data source, and annotation protocol
N/A
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
N/A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
N/A
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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, stylized font, with a horizontal line running through the middle of the letters. Below the word "Pride", the words "Mobility Products Corp." are written in a smaller, less bold font. The logo is black and white.
Research & Development 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990 www.pridemobility.com
Exhibit 1
510(k) Summary Pride Mobility Products Corporation Jazzy Frontie
Submitter's Name & Address:
Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, Pa. 18643 Phone: (570) 655-5574 Facsimile: (570) 655-2990
Contact Person:
Kimberly Blake Official Correspondent
Date Prepared:
9/15/09 .
Name of Device and Proprietary Name:
Name of Beer Pride Mobility Products Corporation
Common or Usual Name:
Powered Wheelchair
Classification Name:
Physical Medicine / Powered Wheelchair
Product Code:
ITI
Comparison to Predicate Devices:
Comparison to Predicate Devices.
The Jazzy Frontie is substantially equivalent to the Pride Mobility Jet 1 (K001970),
The Jazzy Frontie is substantially equivality, and struc The Jazzy Frontie is substantially equivalorite stability, and structure. The when companing performance, maneuvelton of the electronics and drive mechanisms
performance characteristics and the position of the electronics and drive user to maintain performance charactenstics and the position of the one of the user to maintain
are similar to achieve the same intended use function that enables the user to maintain
t and a are similar to domoithout hindering performance.
OCT 23 2009
1
Image /page/1/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a large, bold font, with a horizontal line running through the middle of the letters. Below the word "Pride", the words "Mobility Products Corp." are written in a smaller font. The logo is black and white.
Device Description:
The Jazzy Frontie is a Powered Wheelchair having a digital controller, electrical 140 outly motors, batteries, seating, and frame. The Jazzy Frontie is equipped with electronic, regenerative disc brakes, off-board battery charger, removable 12 Volt U1 batteries, front anti-tip wheels, and rear caster wheels.
The Jazzy Frontie has a depth adjustable fold flat seat that provides fast, simple adjustment for enhanced, personalized comfort that is removable.
The Jazzy Frontie 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 Corp. Jazzy Frontie is to provide mobility to disabled persons having limited walking capabilities.
Non-Clinical Testing:
Compliance to applicable Testing Standards is as follows:
SESNA WC Vol.1 2008 DRAFT - Requirements and Test Methods for Wheelchairs (Including Scooters)
RESNA WC Vol. 2 2008 DRAFT - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems
ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.
IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety CAL 117 - Flammability Testing
Discussion of Clinical Testing Performed:
N/A
Conclusions:
The Jazzy Frontie Powered Wheelchair has the same intended use and similar technological characteristics as the Jet 1 (K001970), 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 Frontie is substantially equivalent to the predicate device, has passed all the necessary testing, and is considered to be safe for user operation.
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Pride Mobility Products Corporation % Ms. Kimberly Blake Official Correspondent 182 Susquehanna Avenue Exeter, Pennsylvania 18643
OCT 2 3 2009
Re: K092961
Trade/Device Name: Jazzy Frontie Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 15, 2009 Received: September 25, 2009
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.
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 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.
3
Page 2 - Ms. Kimberly Blake
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Milken
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exhibit 3
Indications for Use
510(k) Number (if known): K
Device Name: Jazzy Frontie
Indications for Use:
ート - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
The intended use of the Pride Mobility Products Corporation Jazzy Frontie is to The intendou aso of those to a seated position that have the capability of operating a Powered Wheelchair.
AND / OR Prescription Use_ × (Part 21 CFR 801 Subpart D)
X 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)
Yvonne W. Olney FOR M. MELKERSON
Sign Off
(Dision Sign-Off) (DWision Sign-Only)
Division of Surgical, Orthopedic, Division of Surgices Division of Sarge
and Restorative Devices
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510(k) Number -