(240 days)
No
The description focuses on standard powered wheelchair components and a digital controller for basic functions and Bluetooth connectivity, with no mention of AI/ML algorithms or data processing for learning or decision-making.
No
The device is a powered wheelchair designed for mobility, not to treat or cure a medical condition.
No
The device is a powered wheelchair designed to provide mobility, not to diagnose medical conditions or diseases.
No
The device description clearly outlines numerous hardware components including a digital controller, electrical system, motors, encoders, batteries, seating, actuator driven stability system, frame, brakes, and wheels. While it has a digital controller and Bluetooth connectivity, it is fundamentally a powered wheelchair with significant hardware components.
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 description details a powered wheelchair with mechanical and electrical components for movement and stability. 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 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.
- Performance Studies: The performance studies listed are related to the safety and functionality of a wheelchair (e.g., flammability, biocompatibility of materials in contact with skin), not the accuracy or reliability of a diagnostic test.
- Predicate Device: The predicate device is another powered wheelchair, further confirming the device's classification as a mobility aid.
In summary, the Pride Mobility Products Corporation Q6 Edge EM is a medical device, specifically a powered wheelchair, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Pride Mobility Products Corporation Q6 Edge EM 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 Q6 Edge EM is a Powered Wheelchair having a digital controller, electrical system, motors, encoders, batteries, seating, actuator driven stability system, and frame. The Q6 Edge EM is equipped with electronic, regenerative disc brakes, off-board battery charger, removable 12 Volt U1 batteries, and front and rear caster wheels.
The Q6 Edge EM 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.
The Q6 Edge EM will incorporate all of the same features as current devices with elevation, but will utilize a secondary power actuator assembly in the base to lock the casters for additional stability. The actuator will be controlled through the current control system. The addition of the actuator assembly is the reason for this change.
The Q6 Edge EM utilizes a digital controller with a Class 1 Bluetooth®. The actual power output of the Bluetooth® device is 10 dBm (which is 10 mW) maximum output power at 50 Ohm impedance, and the maximum range is 40 m. The specific RF wireless technology type for this Bluetooth® is a Co-existence with IEEE 802.11 (AWMA, AFH). The Bluetooth® has 128-bit encryption security. The Bluetooth® allows clients to connect to a computer, smartphone, and tablet. The Bluetooth® is not active during driving or seating operation.
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
Non-Clinical Testing:
Compliance to applicable Testing Standards is as follows:
- RESNA WC-1:2009 Requirements and Test Methods for Wheelchairs (Including ● Scooters).
- RESNA WC-2:2009 - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems
- California Technical Bulletin 117 - Flammability Test Requirements for Upholstered Furniture
- ISO 8191- 1:1987 Furniture -- Assessment of the ignitability of upholstered ● furniture -- Part 1: Ignition source: smouldering cigarette
- . ISO 8191-1:1988 Furniture -- Assessment of ignitability of upholstered furniture --Part 2: Ignition source: match-flame equivalent
- . AAMI / ANSI / ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity. (Biocompatibility)
- AAMI / ANSI / ISO 10993-10:2010 Biological evaluation of medical devices Part ● 10: Tests for irritation and skin sensitization. (Biocompatibility)
- ANSI/AAMI/ISO 10993-12:2007 Biological evaluation of medical devices Part ● 12: Sample preparation and reference materials.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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/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 an abstract symbol resembling a stylized human figure in profile, with three overlapping faces suggesting community and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 23, 2015
Pride Mobility Product Corporation Kimberly Elmes Verification Manager, Quality Management Systems 182 Susquehanna Avenue Exeter, PA 18643
Re: K143383
Trade/Device Name: 06 Edge EM Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 25, 2015 Received: June 25, 2015
Dear Kimberly Elmes:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Carlos L. Pena 🇿丛
Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143383
Device Name Q6 Edge EM
Indications for Use (Describe)
The intended use of the Pride Mobility Products Corporation Q6 Edge EM is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in large, bold, red letters with a gradient effect, and the registered trademark symbol is in the upper right corner. Below "Pride" is the text "Mobility Products Corp." in a smaller, black font.
Exhibit 1 510(k) Summary Pride Mobility Products Corporation Q6 Edge EM
Submitter's Name & Address:
Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, PA 18643 Phone: (570) 655-5574 Facsimile: (570) 602-4056
Contact Person:
Kimberly Elmes
Date Prepared:
7/14/2015
Name of Device and Proprietary Name:
Q6 Edge EM
Common or Usual Name:
Powered wheelchair
Classification Name:
Physical Medicine / Powered Wheelchair
Product Code:
ITI
Comparison to Predicate Devices:
The Q6 Edge EM is substantially equivalent to the Pride Mobility Jazzy 600 (K042612), 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.
4
Image /page/4/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a large, bold, red font with a gradient effect, making it appear three-dimensional. Below "Pride", the words "Mobility Products Corp." are written in a smaller, black, sans-serif font.
The major differences between the Q6 Edge EM and the Jazzy 600 (K042612) are as follows:
- · The Q6 Edge EM has a lower weight capacity of 200 lbs versus 300 lbs for the Jazzy 600.
- . The Q6 Edge EM is slightly larger dimensionally (47.5" L and 27.5" W) versus the Jazzv 600 (35,25" L and 23,5" W).
- . The Q6 Edge EM utilizes Curtis electronics (previously utilized on K112815 submission) versus Flight electronics on the Jazzy 600.
- . The Q6 Edge EM will utilize a secondary power actuator assembly in the base to lock the casters for additional stability.
Device Description:
The Q6 Edge EM is a Powered Wheelchair having a digital controller, electrical system, motors, encoders, batteries, seating, actuator driven stability system, and frame. The Q6 Edge EM is equipped with electronic, regenerative disc brakes, off-board battery charger, removable 12 Volt U1 batteries, and front and rear caster wheels.
The Q6 Edge EM 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.
The Q6 Edge EM will incorporate all of the same features as current devices with elevation, but will utilize a secondary power actuator assembly in the base to lock the casters for additional stability. The actuator will be controlled through the current control system. The addition of the actuator assembly is the reason for this change.
The Q6 Edge EM utilizes a digital controller with a Class 1 Bluetooth®. The actual power output of the Bluetooth® device is 10 dBm (which is 10 mW) maximum output power at 50 Ohm impedance, and the maximum range is 40 m. The specific RF wireless technology type for this Bluetooth® is a Co-existence with IEEE 802.11 (AWMA, AFH). The Bluetooth® has 128-bit encryption security. The Bluetooth® allows clients to connect to a computer, smartphone, and tablet. The Bluetooth® is not active during driving or seating operation.
Intended Use:
The intended use of the Pride Mobility Products Corporation Q6 Edge EM 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 (Refer to 7F for FDA-3654):
5
Image /page/5/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is in large, red, bold letters with a registered trademark symbol. Below that, the words "Mobility Products Corp." are in a smaller, black font.
- RESNA WC-1:2009 Requirements and Test Methods for Wheelchairs (Including ● Scooters).
- RESNA WC-2:2009 - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems
- California Technical Bulletin 117 - Flammability Test Requirements for Upholstered Furniture
- ISO 8191- 1:1987 Furniture -- Assessment of the ignitability of upholstered ● furniture -- Part 1: Ignition source: smouldering cigarette
- . ISO 8191-1:1988 Furniture -- Assessment of ignitability of upholstered furniture --Part 2: Ignition source: match-flame equivalent
- . AAMI / ANSI / ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity. (Biocompatibility)
- AAMI / ANSI / ISO 10993-10:2010 Biological evaluation of medical devices Part ● 10: Tests for irritation and skin sensitization. (Biocompatibility)
- ANSI/AAMI/ISO 10993-12:2007 Biological evaluation of medical devices Part ● 12: Sample preparation and reference materials.
Discussion of Clinical Testing Performed:
N/A
Conclusions:
The Q6 Edge EM Powered Wheelchair has the same intended use and similar technological characteristics as the Jazzy 600 (K042612), 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 Q6 Edge EM is substantially equivalent to the predicate device, has passed all the necessary testing, and is considered to be safe for user operation