(74 days)
Jazzy 600 (K042612)
Not Found
No
The device description focuses on mechanical and electronic components for basic mobility control (joystick, motors, brakes, controller) and does not mention any AI/ML functionalities.
No
The device is a powered wheelchair designed for mobility, not for treating any specific medical condition or disease. It provides support for individuals limited to a seated position, but its function is assistive and not therapeutic.
No
Explanation: The device description clearly states that the 888 WNLE is a "powered wheelchair" intended to "provide mobility solutions." There is no mention of diagnostic functions or capabilities.
No
The device description clearly details numerous hardware components including motors, brakes, batteries, a controller, and a physical frame, 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 to provide mobility to individuals limited to a seated position. 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 motors, batteries, controls, and seating. These are components of a mobility aid, not equipment used for in vitro diagnostic testing.
- Lack of IVD Characteristics: 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 those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
This device is clearly a medical device intended for mobility assistance, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The intended use of the 888 WNLE powered wheelchair by Pihsiang Machinery Mfg. Co., LTD is to provide mobility solutions to individuals who are limited to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The 888 WNLE is a Center-wheel Drive Powered Wheelchair with front and rear pivoting caster wheels. It is equipped with a pair of electronic 4 pole 24vdc motors, electronic solenoid brakes, and two 12V 60Ah Group M34 batteries. The 888 WNLE is controlled by a PG Drives VR2 controller and is configured for an Off-board Charger. The 888 WNLE has front and rear battery access, and the main frame is composed of a welded steel construction. The 888 WNLE is joystick controlled. which when deflected, informs the controller to release the electromagnetic parking brake and apply power to the motors. This enables the chair to travel in the direction selected by the user with the joystick. When the user releases the joystick, the controller employs regenerative braking to bring the chair to a stop before electromagnetic parking brakes are applied automatically. The 888 WNLE is intended to be driven on various dry outdoor surfaces such as blacktop, concrete, and asphalt.
The 888 WNLE is also equipped with a vinyl Captain's seat with adjustable reclining back. Optional accessories are adjustable height armrests and a center mount foot platform. which help to properly position and support the user.
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)
The 888 WNLE has been tested to evaluate its safety and performance. The 888 WNLE was found to be in compliance with all voluntary test standards referenced above. Performance testing indicates the 888 WNLE is capable of negotiating obstacles up to 80mm in height, is proven to be stable on inclines up to 9°, and capable of theoretical range of 16.4 miles. These results were obtained using the maximum capacity of 300 lbs. These results are well above the requirements of 60mm obstacle height. 7.5° for inclines, and 12 miles for theoretical range. Additional testing has also proven the 888 WNLE is structurally sound, compliant to all electrical, and flammability standards.
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.
Jazzy 600 (K042612)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with flowing lines above them that resemble a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7, 2014
Pihsiang Machinery Mfg. Co., Ltd c/o Dave Yungvirt Third Party Review Group, LLC (TPRG) 45 Rockefellar Plaza. Suite 2000 New York, NY 10111
Re: K142027
Trade/Device Name: 888 WNLE Powered Wheelchair/ROVI X3 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 21, 2014 Received: September 25, 2014
Dear Mr. Yungvirt:
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
1
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 (OS) 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/ResourcesforYou/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.
Felipe Aquel -S
Carlos L. Peña, PhD, MS for 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) K142027
Device Name 888 WNLE Powered Wheelchair/ROVI X3
Indications for Use (Describe)
The intended use of the 888 WNLE powered wheelchair by Pihsiang Machinery Mfg. Co., LTD is to provide mobility solutions to individuals who are limited to a seated position.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| Prescription Use (Per 21 CFR 201.32(e)) Over-The-Counter Use (21 CFR 201.66) | Prescription Use (Per 21 CFR 201.32(e)) | Over-The-Counter Use (21 CFR 201.66) |
| Prescription Use (Per 21 CFR 201.32(e)) | ||
| Over-The-Counter Use (21 CFR 201.66) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | 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 a green logo with a circular design at the top and the word "PIHSIANG" in a stylized font below. The circular design consists of four interconnected, rounded shapes arranged around a central circle. The word "PIHSIANG" is in a metallic green color with a slight gradient effect, and there is a trademark symbol to the right of the word.
Image /page/3/Picture/1 description: The image shows the logo for SHOPRIDER. The logo is red and features a stylized symbol on the left, followed by the word "SHOPRIDER" in a bold, sans-serif font. The letters of the word "SHOPRIDER" have horizontal lines running through them, giving the logo a unique and modern look.
MACHINERY MFG. (
GMP / ISO13485 / ISO9001 / ISO14001 Certified
- World Factory of Most Reliable Consumer Powered Products -
Pihsiang offers you a complete mobility package incorporating world class quality, design, reliability and service.
No. 108 Hsin-He Road, Hsin-Feng Hsiang, HsinChu 304, Taiwan Email: sales@pihsiang.com.tw Tel:+886-3-568-8585 Fax: +886-3-568-8855
510(k) Summary 888 WNLE Power Wheelchair
Submitter's Name & Address:
Pihsiang Machinery Mfg. Co., LTD. No. 108 Hsin-He Road, Hsin-Feng Hsiang HsinChu 304, Taiwan Phone: +886-3-568-8585 Ext. 1500 Fax: +886-3-568-8855 Contact Name: Edwin Huang Contact Title: Corporate Compliance Officer Contact E-mail: edwinhuang@mail.pihsiang.com.tw
Official Correspondent
Name: David Lin Title: President, Shoprider Mobility Products, Inc. Email: dlin@shoprider.com Phone: 310-328-8866 Ext. 102 Fax: 310-328-8185
Date Prepared: September 22nd, 2014
Name of Device and Proprietary Name:
Pihsiang Machinery Mfg. Co. LTD Model: 888 WNLE Powered Wheelchair Shoprider Mobility Products, Inc. Marketed name: Rovi X3
Common or Usual Name:
Powered Wheelchair
Classification Name:
Wheelchair, Powered, Class II, 21 CFR 890.3860
Product Code: ITI
|||
Indications for Use:
The intended use of the 888 WNLE powered wheelchair by Pihsiang Machinery Mfg. Co., LTD is to provide mobility solutions to individuals who are limited to a seated position.
4
Image /page/4/Picture/0 description: The image displays the logos and name of Pihsiang Machinery MFG. CO., LTD. The left side of the image features a green logo with a stylized design, accompanied by the name "PIHSIANG" in a stylized font. To the right, the image showcases the "SHOPRIDER" logo in red, followed by the company's name in bold, black letters. The image also includes the certifications GMP/ISO13485 / ISO9001 / ISO14001 and the text "World Factory of Most Reliable Consumer Powered Products".
No. 108 Hsin-He Road, Hsin-Feng Hsiang, HsinChu 304, Taiwan Email: sales@pihsiang.com.tw Tel:+886-3-568-8585 Fax: +886-3-56
Device Description:
The 888 WNLE is a Center-wheel Drive Powered Wheelchair with front and rear pivoting caster wheels. It is equipped with a pair of electronic 4 pole 24vdc motors, electronic solenoid brakes, and two 12V 60Ah Group M34 batteries. The 888 WNLE is controlled by a PG Drives VR2 controller and is configured for an Off-board Charger. The 888 WNLE has front and rear battery access, and the main frame is composed of a welded steel construction. The 888 WNLE is joystick controlled. which when deflected, informs the controller to release the electromagnetic parking brake and apply power to the motors. This enables the chair to travel in the direction selected by the user with the joystick. When the user releases the joystick, the controller employs regenerative braking to bring the chair to a stop before electromagnetic parking brakes are applied automatically. The 888 WNLE is intended to be driven on various dry outdoor surfaces such as blacktop, concrete, and asphalt.
The 888 WNLE is also equipped with a vinyl Captain's seat with adjustable reclining back. Optional accessories are adjustable height armrests and a center mount foot platform. which help to properly position and support the user.
Predicate Device:
Jazzy 600 (K042612)
Predicate Device Indications for Use:
The intended use of the Pride Mobility Products Corp. Jazzy 600 Powered Wheelchair is to provide mobility to persons limited to a seated position.
Comparison to Predicate Devices:
The 888 WNLE is substantially equivalent to the Pride Mobility Jazzy 600 (K042612) when comparing performance, maneuverability, stability, and dimensions. Both the 888 WNLE and Jazzy 600 (K042612) utilize a center mounted drive wheel with front and rear casters (on the ground) to maintain stability. The 888 WNLE is equipped with a suspension that allows the unit to achieve the same Intended use of the Jazzy 600, providing mobility to persons limited to a seated position, while maintaining optimal stability and without hindering performance. Both the 888 WNLE and the Jazzy 600 (K042612) utilize side mounted freewheel levers, and are equipped with PG Drives VR2 motor control systems. The technical differences that exist between the 888 WNLE and the Jazzy 600 (K042612) are few. While the 888 WNLE is equipped with a larger capacity battery 60Ah 12vdc (Group M34), it is the same type of energy source utilized in the Jazzy 600 (K042612). 55Ah 12Vdc battery (Group NF22). Another difference is that the 888 WNLE is designed for front and rear battery access while the Jazzy 600 (K042612) is designed for front battery access only. Finally the 888 WNLE is equipped with two 4 pole 24vdc motors while the Jazzy 600 (K042612) is equipped with two 2 pole 24vdc motors. The addition of the
5
Image /page/5/Picture/0 description: The image shows a logo with a green abstract symbol on top and the word "PIHSIANG" in gold below. The symbol consists of four curved shapes arranged around a central circle, resembling a stylized flower or clover. The word "PIHSIANG" is written in a serif font, with a registered trademark symbol to the right of the word.
Image /page/5/Picture/1 description: The image shows the logo for Shoprider. The logo is red and features a stylized symbol on the left, resembling a wheel or gear. To the right of the symbol is the word "SHOPRIDER" in a bold, stylized font, with horizontal lines running through each letter. There is a registered trademark symbol to the right of the word.
PIHSIANG MACHINERY MFG. CO., LTD.
GMP / ISO13485 / ISO9001 / ISO14001 Certified
- World Factory of Most Reliable Consumer Powered Products -
Pihsiang offers you a complete mobility package incorporating world class quality, design, reliability and service.
No. 108 Hsin-He Road, Hsin-Feng Hsiang, HsinChu 304, Taiwan Email: sales@pihsiang.com.tw Tel:+886-3-568-8585 Fax: +886-3-568-8855
extra 2 poles to the drive motor provide for extra power and enables the 888 WNLE to provide the necessary performance to fulfill its intended use.
Non-Clinical Testing:
RESNA WC Vol.1 2009 - Requirements and Test Methods for Wheelchairs (Including Scooters)
Section 1: Determination of Static Stability
Section 5: Determination of dimensions, mass, and maneuvering space
Section 7: Method of measurement of seating and wheel dimensions
Section 8: Requirements and test methods for static, impact and fatigue strengths
- Section 11: Test Dummies
Section 13: Determination of coefficient of friction of test surfaces
Section 15: Requirements for information disclosure, documentation and labeling
- Section 16: Resistance to Ignition of Upholstered Parts Requirements and Test Methods
- Section 22: Set-up procedures
Section 26: Vocabulary
RESNA WC Vol. 2 2009 - Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems
Section 2: Determination of dynamic stability of electrically powered wheelchairs Section 3: Determination of effectiveness of brakes
Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range
Section 6: Determination of maximum speed, acceleration and deceleration of electrically powered wheelchairs
Section 9: Climatic tests for electrically powered wheelchairs
Section 10: Determination of obstacle -- climbing ability of electrically powered wheelchairs Section 14: Power and control systems for electrically powered wheelchairs - requirements and test methods
Section 21: Requirements and Test Methods for Electromagnetic Compatibility of electrically powered wheelchairs and motorized scooters
ISO 14971: 2009 Medical devices -- Application of risk management to medical devices
Compliance to ISO 10993 Biocompatibility
Summary of Excluded Section:
Certain sections of RESNA WC-11-2: 2009 were not evaluated because they were specific to features not available or applicable to 888 WNLE. The subsections are detailed in FDA-3654 Standards and Data Report forms.
6
Image /page/6/Picture/0 description: The image shows the logos for PIHSIANG and SHOPRIDER, along with the text "PIHSIANG MACHINERY MFG. CO., LTD." The text "GMP / ISO13485 / ISO9001 / ISO14001 Certified" is also present, indicating that the company is certified in these areas. Finally, the text "- World Factory of Most Reliable Consumer Powered Products -" is included, suggesting that the company manufactures consumer products.
- World Factory of Most Reliable Consumer Powered Products -
Pihsiang offers you a complete mobility package incorporating world class quality, design, reliability and service.
No. 108 Hsin-He Road, Hsin-Feng Hsiang, HsinChu 304, Taiwan Email: sales@pihsiang.com.tw Tel:+886-3-568-8585 Fax: +886-3-568-8855
Conclusion of Non-Clinical Testing:
The 888 WNLE has been tested to evaluate its safety and performance. The 888 WNLE was found to be in compliance with all voluntary test standards referenced above. Performance testing indicates the 888 WNLE is capable of negotiating obstacles up to 80mm in height, is proven to be stable on inclines up to 9°, and capable of theoretical range of 16.4 miles. These results were obtained using the maximum capacity of 300 lbs. These results are well above the requirements of 60mm obstacle height. 7.5° for inclines, and 12 miles for theoretical range. Additional testing has also proven the 888 WNLE is structurally sound, compliant to all electrical, and flammability standards. Biocompatibility for polyurethane vinyl (seat) and polyurethane foam (armrests) has previously been evaluated and cleared under ITI powered wheelchair TE 888W (K983808). Exclusions to the voluntary standards listed above are detailed in FDA-3654 Standards and Data Reports.
Discussion of Clinical Testing Performed: N/A
Conclusions:
The 888 WNLE has an equivalent intended use and similar technological characteristics as the Jazzy 600 (K042612). The results of non-clinical testing and the comparison of the 888 WNLE to the Jazzy 600 (K042612) have proven that the technical differences do not raise any new questions of safety or effectiveness. Based on these findings, it is the assertion that the 888 WNLE is substantially equivalent to the Pride Mobility Jazzy 600 (K042612) and is safe for the Intended Use.