(387 days)
No
The description mentions "operation and safety algorithms" and a "Main Controller" that performs "balancing and safety algorithms," but there is no mention of AI, ML, or any related concepts like training data, test data, or specific AI/ML techniques. The functionality described appears to be based on traditional control systems and sensors.
Yes
Explanation: The device is described as "intended for medical purposes to provide mobility to persons restricted to a sitting position," which indicates its use in aiding individuals with medical conditions, classifying it as a therapeutic device.
No.
The document describes a power wheelchair intended for mobility, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components including a motorized driving chassis, batteries, steel frame, Inertial Measurement Unit, motor-based lifting mechanism, balancing platform, user interface module with a joystick and display, actuator drivers, and a main controller. This is clearly a physical medical device with integrated software, not a software-only device.
Based on the provided information, the UPnRIDE™ stand-up power wheelchair is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide mobility to persons restricted to a sitting position. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a mechanical and electronic device for mobility and positioning. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological samples
- Diagnostic results or measurements of biological markers
- Image processing of biological samples
The UPnRIDE™ is clearly a medical device designed for physical assistance and mobility, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The UPnRIDE™ stand-up power wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position. The product changes position from Sitting to Standing and Standing to Sitting but also any position in between. The product provides indoor and outdoor mobility.
Product codes (comma separated list FDA assigned to the subject device)
IPL
Device Description
The UPnRIDE™ device enables disabled and elderly individuals to be mobile in a sitting or standing position indoors and outdoors.
The device design is based on the following principles:
- Using motorized jointed braces and harnessing to safely support the user while sitting, shifting to standing, standing and returning to sitting
- Center of gravity (COG) is maintained substantially at the center of the device in all positions, thus maximizing stability and safety.
- Balancing the platform which supports the user so that the user always remains vertical even on skewed surfaces.
- Implementing an operation and safety algorithms to minimize risks and hazards to the user, even beyond the provisions of standard wheelchairs.
The product is comprised of the following modules:
- Driving module: a motorized driving chassis that includes two front motorized wheels, two high capacity Li-Ion batteries 21.6VDC / 29.7Ah and a steel frame which is installed as a chassis for the device's components.
- Inertial Measurement Unit ("IMU") for measuring ground slopes (pitch and roll) and user's tilt angles (pitch and roll).
- Standing and sitting module: a motor-based lifting mechanism for shifting between standing and sitting positions.
- Balancing module: a platform that balances the user while sitting or standing, relative to earth.
- User interface module: a unit through which the user controls the UPnRIDE™. This module has an "R-NET" controller that contains a Joystick, commanding buttons and a display for viewing indications and status and a switching box for controlling the various modes of operation.
- Actuator drivers: five units that control the lifting motors.
- Main Controller: a unit which reads all sensors and user inputs, performs the balancing and safety algorithms, and controls all the chairs function.
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)
No Clinical Testing is required for this submission. The performance tests and the clinical study that were conducted show that the UPnRIDE™ is substantially equivalent to the listed predicate devices without raising any new safety and effectiveness questions.
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.
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
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).
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September 12, 2019
UPnRIDE Robotics Ltd. % Yoram Levy Qsite General Manager Osite 31 Haavoda St. Binyamina, 30500 Israel
Re: K182257
Trade/Device Name: UPnRIDE Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: Class II Product Code: IPL Dated: July 15, 2019 Received: July 22, 2019
Dear Yoram Levy:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek Pinto, Ph.D. Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182257
Device Name UPnRIDE
Indications for Use (Describe)
The UPnRIDE™ stand-up power wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position. The product changes position from Sitting to Standing and Standing to Sitting but also any position in between. The product provides indoor and outdoor mobility.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for UpnRIDE Robotics LTD. The logo has the word "UP" in gray, followed by a blue square with a lowercase "n" in white. The word "RIDE" is in purple, and below it is the text "ROBOTICS LTD." in a smaller font, also in purple.
510(K) SUMMARY
UPnRIDE
510(k) Number K182257
| Applicant's Name: | UPnRIDE Robotics Ltd.
Kochav Yokneam Bld.
Yokneam Ilit 2069204
Israel.
TEL: (972)4-611-0061
FAX: (972)4-611-3313 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite
31 Haavoda St.
Binyamina, Israel 3054431
Tel (972)4-638-8837; Fax (972)4-638-0510
Yoram@qsitemed.com |
| Trade Name: | UPnRIDE™ |
| Summary
Preparation Date: | August 8, 2018 |
| Classification: | Classification name: Standup wheelchair
Product Code: IPL
Regulation No: 21 CFR 890.3900
Class: II
Panel: Physical Medicine |
| Device Description: | The UPnRIDE™ device enables disabled and elderly
individuals to be mobile in a sitting or standing position
indoors and outdoors.
The device design is based on the following principles:
- Using motorized jointed braces and harnessing to safely
support the user while sitting, shifting to standing, standing
and returning to sitting |
-
- Center of gravity (COG) is maintained substantially at the center of the device in all positions, thus maximizing stability and safety.
-
- Balancing the platform which supports the user so that the user always remains vertical even on skewed surfaces.
4
Image /page/4/Picture/0 description: The image is a logo for "UPnRIDE ROBOTICS LTD." The "UP" is in a dark gray font, and the "n" is in a blue rounded square. The "RIDE" is in a purple font, and "ROBOTICS LTD." is in a smaller font below "RIDE".
-
- Implementing an operation and safety algorithms to minimize risks and hazards to the user, even beyond the provisions of standard wheelchairs.
The product is comprised of the following modules:
- Implementing an operation and safety algorithms to minimize risks and hazards to the user, even beyond the provisions of standard wheelchairs.
-
Driving module: a motorized driving chassis that 1. includes two front motorized wheels, two high capacity Li-Ion batteries 21.6VDC / 29.7Ah and a steel frame which is installed as a chassis for the device's components.
-
Inertial Measurement Unit ("IMU") for measuring 2. ground slopes (pitch and roll) and user's tilt angles (pitch and roll).
-
Standing and sitting module: a motor-based lifting 3. mechanism for shifting between standing and sitting positions.
-
- Balancing module: a platform that balances the user while sitting or standing, relative to earth.
-
- User interface module: a unit through which the user controls the UPnRIDE™. This module has an "R-NET" controller that contains a Joystick, commanding buttons and a display for viewing indications and status and a switching box for controlling the various modes of operation.
-
Actuator drivers: five units that control the lifting 6. motors.
-
- Main Controller: a unit which reads all sensors and user inputs, performs the balancing and safety algorithms, and controls all the chairs function.
5
Image /page/5/Picture/0 description: The image shows the logo for UpnRIDE Robotics LTD. The logo has the word "UP" in gray, a blue square with a lowercase "n" in white, and the word "RIDE" in purple. Underneath the word "RIDE" is the text "ROBOTICS LTD." in a smaller font.
Indications for Use:
The UPnRIDETM stand-up power wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position. The product changes people's position from Sitting to Standing and Standing to Sitting but also any position in between. The product provides indoor and outdoor mobility.
Predicate Devices:
Substantial equivalence to the following predicate and reference devices is
| Device Name | 510k No | Date of Clearance | |
|---|---|---|---|
| Predicate | Levo comfort II | K051387 | June 10, 2005 |
| Reference | Quickie® Q700-UP M | K172384 | January 16, 2018 |
claimed:
Comparison with Predicate Devices
Intended use and indications for use
The UPnRIDE™ stand-up power wheelchair is a product which changes people's position from sitting to standing and standing to sitting but also any position in between, same as the cleared Levo comfort II (K051387). Both devices are intended to allow indoor and outdoor mobility.
The proposed UPnRIDE™ and the two predicate devices: the Levo comfort II and the Q700-UP M (K172384) wheelchairs are intended for any individual who needs a power wheelchair and cannot stand up on their own.
The UPnRIDE™ can be used on uneven ground, same as with the Levo comfort II and the Q700-UP M.
The UPnRIDE™ is classified as a standup wheelchair, under the regulation code IPL (regulation number 890.3900), same as the Levo comfort II (K051387) and the Q700-UP M (K172384). The devices are Class II devices.
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Image /page/6/Picture/0 description: The image is a logo for a company called "UPn RIDE ROBOTICS LTD." The word "UP" is in gray, and the letter "n" is inside a blue rounded square. The word "RIDE" is in purple, and the words "ROBOTICS LTD." are in a smaller font below the word "RIDE."
Technical Comparison
Both the UPnRIDE™, the Levo Comfort II and the Q700-UP M devices contain two main modules. The first one is a driving module that includes a steel frame, two drive motors and batteries as a source of energy. The second is a sitting-standing module, which enables the user adjust the chair according to the user's demand. The components of the sitting-standing adjustment module of the UPnRIDE™ device are similar to the cleared reference device- Q700-UP M powered wheelchair and includes several motors, that allow the user to transfer from a sitting to a standing position and vice versa, to amend the positions of the leg support, back support and chair's horizontal and vertical locations while sitting and standing, like the Q700-UP M.
Both UPnRIDE™ and the predicate devices include a controller which contains a joystick and command buttons designed by PG Drives Technology. In addition, both UPnRIDETM device and Q700-UP M contain the same braking system which is based on PG Drives Technology.
UPnRIDE™ includes additional module - Balancing module. UPnRIDE™ proprietary balancing system enables the user to be mobile on almost any urban environment with increased safety. Using two linear actuators, the system balances the platform which supports the user so that the user always remains vertical even on skewed surfaces. The balancing operation was validated by multitude performance tests and a usability study to ensure its efficiency and to prevent any safety concerns.
Both UPnRIDE™ and the predicate devices have similar characteristics such as user weighing up, maximum curb height and distance range.
Performance Standards
UPnRIDETM complies with the following voluntary standards:
-
- ISO 7176-1:1999 Wheelchairs Part 1: Determination of static stability.
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Image /page/7/Picture/0 description: The image shows the logo for "UPnRIDE ROBOTICS LTD." The words "UP" and "RIDE" are in large, bold fonts, with "UP" in black and "RIDE" in purple. Between the two words is a blue square with rounded corners, containing a white letter "n". Below the word "RIDE" is the text "ROBOTICS LTD." in a smaller font.
-
- ISO 7176-2:2001 Wheelchairs Part 2: Determination of dynamic stability of electric wheelchairs.
-
- ISO 7176-3:2012 Wheelchairs Part 3: Determination of effectiveness of brakes
-
- ISO 7176-4:2008 Wheelchairs Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range.
- ર. ISO 7176-5:2008 Determination of dimensions, mass and maneuvering space.
-
- ISO 7176-6:2001 Wheelchairs Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs.
-
- ISO 7176-8:2014 Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths- clauses 8-9 (static, impact strength).
-
- ISO 7176-9:2009 Wheelchairs Part 9: Climatic tests for electric wheelchairs
-
- ISO 7176-10:2008 Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
-
- ISO 7176-11:2012 -Wheelchairs Part 11: Test dummies
-
- ISO 7176-13:2008 Determination of coefficient of friction of test surfaces
-
- ISO 7176-14 :2008 Wheelchairs Part 14: Power and control systems for electrically powered wheelchairs and scooters -Requirements and test methods
-
- ISO 7176-15 -: 1996 Wheelchairs Part 15: Requirements for information disclosure, documentation and labelling.
-
- ISO 7176-16 :2012 Resistance to ignition of upholstered parts - Requirements and test methods.
-
- ISO 7176-21-:2009 Wheelchairs Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers.
-
- ISO 7176-25:2013 Requirements and test methods for batteries and battery chargers intended for use with electrically powered wheelchairs
-
- ANSI/RESNA WC-1: 2009, Section 20 -American National Standard for Wheelchairs -Volume 1: Requirements and Test Methods for Wheelchairs
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Image /page/8/Picture/0 description: The image is a logo for a company called "UPnRIDE ROBOTICS LTD." The logo has the word "UP" in gray, followed by a blue square with a lowercase "n" inside. The word "RIDE" is in purple, and the words "ROBOTICS LTD." are in a smaller font below the word "RIDE". The logo is simple and modern, and it uses a limited color palette.
Summary of Clinical Performance Data:
No Clinical Testing is required for this submission
Substantial equivalence conclusion
The performance tests and the clinical study that were conducted show that the UPnRIDE™ is substantially equivalent to the listed predicate devices without raising any new safety and effectiveness questions.