(159 days)
Not Found
No
The description details a standard powered wheelchair controlled by a joystick and a basic controller, with no mention of AI or ML capabilities.
No.
The device is a powered wheelchair intended for mobility, not to treat or cure a disease or condition.
No
The device description indicates it is a powered wheelchair for mobility, not a device used to diagnose medical conditions.
No
The device description clearly outlines a physical powered wheelchair with hardware components such as motors, batteries, frame, wheels, and a joystick. While it includes a controller, the primary function and description are centered around the physical mobility device, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Merits Model P322 Powered Wheelchair is a device for providing mobility to individuals with limited mobility. It is a mechanical and electrical device for transportation.
- Intended Use: The intended use is for "outdoor and indoor mobility to persons limited to a seated position." This is a functional purpose, not a diagnostic one.
- Lack of Diagnostic Elements: The description does not mention any components or functions related to analyzing biological samples, detecting biomarkers, or diagnosing medical conditions.
The device is a mobility aid, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Merits Model P322 Powered Wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
Model P322 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the PG power wheelchair VR-2 50amp controller. The user interface is a joystick. P322 is powered by two 12 VDC 34ah (U1) batteries. The batteries are charged by 4A off-board charger connect with 3-pin Microphone Connector to charging socket on joystick. The approximate driving range on fully charged batteries is up to 28km (18mi). The chair frame is a rived nut and welded steel construction and includes two front drive wheels with drive units (including motor, gear, brake), batteries and rear pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the wheelchair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.
The upholstery of the device complies with EN 1021-1/-2:2006: Furniture: Assessment of the ignitability of upholstered furniture: Ignition source: Smouldering cigarette/ Match flame equivalent
The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
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 tests performed:
ISO 7176-1:1999 Determination of Static Stability
ISO 7176-2:2001 Determination of Dynamic Stability of electric wheelchairs
ISO 7176-3:2003 Determination of effectiveness of brakes
ISO 7176-4:2008 Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-5:2008 Determination of overall dimensions, mass and maneuvering space of speed. Determination maximum acceleration and deceleration of electric wheelchairs
ISO 7176-7:1998 Method of Measurement of Seating and Wheel Dimensions
ISO 7176-8:1998 Requirements and test methods for static, impact and fatigue strengths
ISO 7176-9:2009 Climatic tests for wheelchairs
ISO 7176-10:2008 Determination of obstacle-climbing ability of electrically power wheelchairs
ISO 7176-11:1992 Test dummies
ISO 7176-13:1989 Determination of coefficient of friction of test surfaces
ISO 7176-14:2008 Power control systems for electrically powered and wheelchairs and scooter- Requirements and test methods.
ISO 7176-15:1996 Requirements for Information Disclosure, Documentation and Labeling
IEC 60601-1:1988 Medical electrical equipment Part 1: General requirements for safety
IEC 60601-1-2:2007 Electromagnetic Compatibility Requirements and Tests
ISO 14971:2007 Medical devices -- Application of risk management to medical devices
EN 1021-1:2006 Furniture Assessment of the ignitability of upholstered furniture : Ignition source: Smouldering cigarette
EN 1021-2:2006 Furniture Assessment of the ignitability of upholstered furniture : Ignition source: Match flame equivalent
Key results: The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
JAN
9 2013
510(k) SUMMARY
Merits Health Products Co., LTD. 510(k) Premarket Notification
Submitter:
Merits Health Products Co., LTD. No.18, Jingke Rd., Nantun Dist. Taichung City 40852, Taiwan (R.O.C.)
Contact Person:
Vincent Chen Merits Health Products Co., LTD. No.18, Jingke Rd., Nantun Dist., Taichung City 40852, Taiwan (R.O.C.) Phone: +886-4-23594985 ext.200 Fax: +886-4-23503962
Date Prepared:
July 30, 2012
Proprietary Name:
Merits Model P322 Powered Wheelchair .
Common name:
Powered Wheelchair
Classification name:
1
Powered Wheelchair
Comparison to Predicate Devices:
This submission indicates the Substantial Equivalence of Merits Model P322 FWD Powered Wheelchair with the predicate Hoveround Teknique FWD mk4 Power Chair (K090108). P322 has the same intended uses and similar indications, technological characteristics and principles of operation with predicate device.
1
Device Description
Model P322 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the PG power wheelchair VR-2 50amp controller. The user interface is a joystick. P322 is powered by two 12 VDC 34ah (U1) batteries. The batteries are charged by 4A off-board charger connect with 3-pin Microphone Connector to charging socket on joystick. The approximate driving range on fully charged batteries is up to 28km (18mi). The chair frame is a rived nut and welded steel construction and includes two front drive wheels with drive units (including motor, gear, brake), batteries and rear pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the wheelchair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.
The upholstery of the device complies with EN 1021-1/-2:2006: Furniture: Assessment of the ignitability of upholstered furniture: Ignition source: Smouldering cigarette/ Match flame equivalent
The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
The Merits Model P322 is substantially equivalent to Hoveround Teknique FWD mk4 Power Chair (K090108). Both products are battery power, motorized designed for use with powered wheelchairs. Performance characteristics and drive mechanisms are similar and all have the same intended function and use which is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair. Additional, they are all constructed from the same basic materials, have the same basic operational principles and all use DC batteries as their source of power.
Although there are some minor differences between P322 and its predicate device. But they raise no new issues of safety or effectiveness. Performance data demonstrate that P322 is safe. The non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do no raise any new questions of safety or effectiveness.
Intended Use
The Merits Model P322 Powered Wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
2
Discussion of Non-clinical Tests Performed for Determinations of Substantial equivalence are as follows:
ISO 7176-1:1999 Determination of Static Stability
ISO 7176-2:2001 Determination of Dynamic Stability of electric wheelchairs
ISO 7176-3:2003 Determination of effectiveness of brakes
Energy consumption of electric wheelchairs and scooters for ISO 7176-4:2008 determination of theoretical distance range
-
Determination of overall dimensions, mass and maneuvering ISO 7176-5:2008 space
of speed. Determination maximum acceleration and ISO 7176-6:2001 deceleration of electric wheelchairs -
ISO 7176-7:1998 Method of Measurement of Seating and Wheel Dimensions
Requirements and test methods for static, impact and fatigue ISO 7176-8:1998 strengths
ISO 7176-9:2009 Climatic tests for wheelchairs
Determination of obstacle-climbing ability of electrically power ISO 7176-10:2008 wheelchairs
ISO 7176-11:1992 Test dummies
ISO 7176-13:1989 Determination of coefficient of friction of test surfaces
ISO 7176-14:2008 Power control systems for electrically powered and wheelchairs and scooter- Requirements and test methods.
-
Requirements for Information Disclosure, Documentation and ISO 7176-15:1996 Labeling
Medical electrical equipment Part 1: General requirements for IEC 60601-1:1988 safety -
IEC 60601-1-2:2007 Electromagnetic Compatibility Requirements and Tests
-
Medical devices -- Application of risk management to medical ISO 14971:2007 devices
-
Furniture Assessment of the ignitability of upholstered EN 1021-1:2006 furniture : Ignition source: Smouldering cigarette
Furniture Assessment of the ignitability of upholstered EN 1021-2:2006 furniture : Ignition source: Match flame equivalent
The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
Conclusions
According to comparison table, the differences on weight capacity, function of elevate, recline and dimension of width do not deleteriously affect the safety and effectiveness of the device.
So based on the design, performance specifications and testing and intended use, the Merits Model P322 Powered Wheelchair is substantially equivalent to Hoveround Teknique FWD mk4 Power Chair (K090108).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Merits Health Products CO., LTD Mr. Vincent Chen No. 18 Jingke Road Nantun Dist Taichung China (Taiwan) 40852
JAN
9 2013
Re: 510(k) Number: K122357
Trade/Device Name: Merits Model P322 Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 21, 2012 Received: December 26, 2012
Dear Mr.Chen:
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
4
Page 2 - Mr. Vincent Chen
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) File Number:
Device Name: Merits Model P322 Powered Wheelchair
Indications for Use: The Merits Model P322 Powered Wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Prescription Use_ V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Brian D.Pullin -S
Division of Neurological and Physical Medicine Devices 510(k) Number: 1122357