(105 days)
The F5 Corpus VS powered wheelchair is to provide indoor mobility, including stand-up feature, to persons limited to a seating position that are capable of operating a powered wheelchair.
F5 Corpus VS Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick. The F5 Corpus VS is powered by two 12VDC, Group M24, approximate driving range on fully charged batteries is up to 25km (15.5 miles), depending on use and the terrain the chair is driven on. The chair frame is a steel construction and includes two front drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's 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 chair is allowed to move in 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 to stop by letting go of the joystick. F5 Corpus VS will enable the user to stand up, completely or partially, to facilitate reaching, working eye to eye with colleagues. The standing sequence is controlled by the joystick and gives the user the possibility to come to a standing position. The seating, chest support and knee stop stabilize the user during the stand-up or sitdown operation.
This document (K191874) is a 510(k) premarket notification for a powered wheelchair, the F5 Corpus VS. It compares the device to two predicates: the Quickie® Q700-UP M (K172384) and the F5 (K143014).
Based on the provided text, here is an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally demonstrated by compliance with various ISO and RESNA standards for wheelchairs. The document does not present a single table explicitly listing "acceptance criteria" against "reported device performance" in a quantitative manner for all aspects. Instead, it states compliance with standards and provides some performance specifications when comparing the device to its predicates.
Here's an attempt to compile relevant information, though a direct "acceptance criteria" column is not explicitly defined in the document for each performance characteristic:
| Performance Characteristic | Acceptance Criteria (Implied by Standards) | Reported Device Performance (F5 Corpus VS) |
|---|---|---|
| Static Stability | Complies with ISO 7176-1:1999 | Complies with ISO 7176-1:1999 |
| Dynamic Stability | Complies with ISO 7176-2:2001 | Complies with ISO 7176-2:2001 |
| Brake Effectiveness | Complies with ISO 7176-3:2003 | Complies with ISO 7176-3:2003 |
| Energy Consumption / Theoretical Distance Range | Complies with ISO 7176-4:2008 | Complies with ISO 7176-4:2008 |
| Overall Dimensions, Mass, Maneuvering Space | Complies with ISO 7176-5:2008 | Complies with ISO 7176-5:2008 |
| Maximum Speed, Acceleration, Deceleration | Complies with ISO 7176-6:2001 | Complies with ISO 7176-6:2001 (Max speed: Up to 12 km/h (7.5 mph) forward, 4.4 km/hr (3 mph) reverse) |
| Seating and Wheel Dimensions | Complies with ISO 7176-7:1998 | Complies with ISO 7176-7:1998 |
| Static, Impact, Fatigue Strengths | Complies with ISO 7176-8:1998 | Complies with ISO 7176-8:1998 |
| Climatic Tests | Complies with ISO 7176-9:2009 | Complies with ISO 7176-9:2009 |
| Obstacle-Climbing Ability | Complies with ISO 7176-10:2008 | Complies with ISO 7176-10:2008 (Max obstacle height: 3" / 75 mm, not in standing mode) |
| Test Dummies | Complies with ISO 7176-11:2012 | Complies with ISO 7176-11:2012 |
| Coefficient of Friction of Test Surfaces | Complies with ISO 7176-13:1989 | Complies with ISO 7176-13:1989 |
| Power and Control Systems | Complies with ISO 7176-14:2008 | Complies with ISO 7176-14:2008 (PG R-Net PM 120 120Amp electronics) |
| Information Disclosure, Documentation, Labeling | Complies with ISO 7176-15:1996 | Complies with ISO 7176-15:1996 |
| Resistance to Ignition of Postural Support Devices | Complies with ISO 7176-16:2012 | Complies with ISO 7176-16:2012 |
| Wheeled Mobility Devices for Use as Seats in Motor Vehicles | Complies with ISO 7176-19:2008 | Complies with ISO 7176-19:2008 |
| Electromagnetic Compatibility (EMC) | Complies with ISO 7176-21:2009 | Complies with ISO 7176-21:2009 (20V/m modulated 80% AM) |
| Set-up Procedures | Complies with ISO 7176-22:2014 | Complies with ISO 7176-22:2014 |
| Batteries and Chargers | Complies with ISO 7176-25:2013 | Complies with ISO 7176-25:2013 (2 x 12V 73 Ah gel Group M24 battery) |
| Vocabulary | Complies with ISO 7176-26:2007 | Complies with ISO 7176-26:2007 |
| Performance of Stand-up Type Wheelchairs | Complies with RESNA WC-1:2009 Section 20 | Complies with RESNA WC-1:2009 Section 20 |
| Maximum Incline Angle | Maximum incline angle for safe operation | 9° |
| Driving Range | Acceptable driving range for powered wheelchairs | Up to 25 km (16 miles) on fully charged battery |
| Weight Bearing Capacity | Max user weight | 136 kg (300 lbs) |
| Turning Radius | Within acceptable limits for maneuverability | 762.5 mm (30") |
The document emphasizes that the F5 Corpus VS passes the requirements in ISO 7176 and RESNA WC-1:2009 Section 20.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document refers to "Non-Clinical Testing" which involves compliance with a long list of ISO standards and RESNA WC-1. These are physical performance tests for the device itself (e.g., stability, brake effectiveness, strength).
- Sample size for the test set: Not explicitly stated as a number of devices or units. Typically, for device performance testing against standards, a representative sample (e.g., a few units or prototypes) is tested. The nature of these tests does not involve patient data or human subjects for the "test set" in the context of an AI/algorithm study.
- Data provenance: Not applicable in the context of patient data for an algorithm. The tests are for the physical wheelchair device. The Permobil AB company is based in Sweden. The tests were conducted to international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable as the device is a physical powered wheelchair, not an AI/algorithm that requires expert-established ground truth from medical images or patient data. The "ground truth" here is the physical performance of the device as measured by standardized engineering and safety tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as the device is a physical powered wheelchair, not an AI/algorithm study involving adjudication of clinical findings. Compliance with standards is typically measured objectively through specified test procedures.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a physical powered wheelchair. There is no AI component or human reader in the context of medical image interpretation that would warrant an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical powered wheelchair, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the F5 Corpus VS device is its physical performance, safety, and functional characteristics as measured and validated against established international standards (ISO 7176 series and RESNA WC-1:2009 Section 20). These standards define objective test methods and acceptable performance limits.
8. The sample size for the training set
This information is not applicable. The device is a physical powered wheelchair. There is no AI/algorithm being trained on a dataset. The design and manufacturing process would involve engineering principles and testing, not machine learning training.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as in point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
October 25, 2019
Permobil AB Ivan Fernandez Director of Regulatory Compliance Box 120 S-861 23 Timrå Sweden
Re: K191874
Trade/Device Name: F5 Corpus VS Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: Class II Product Codes: IPL, ITI Dated: September 26, 2019 Received: September 26, 2019
Dear Ivan Fernandez:
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.
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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 mediation-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.
For: Vivek J. Pinto, PhD 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
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Indications for Use
510(k) Number (if known) K191874
Device Name F5 Corpus VS
Indications for Use (Describe)
The F5 Corpus VS powered wheelchair is to provide indoor mobility, including stand-up feature, to persons limited to a seating position that are capable of operating a powered wheelchair.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Part 21 CFR 201. Subpart D) |
|---|
| ☒ Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: F5 CORPUS VS
Image /page/3/Picture/1 description: The image shows the Permobil logo. The word "permobil" is written in a blue, sans-serif font. Below the word "permobil" is the phrase "THE POWER OF MOBILITY" in a smaller, black, sans-serif font. The logo is simple and modern.
Section 5. 510(k) Summary
Submitter Permobil AB Box 120 S-861 23 Timrå Sweden
Phone: +46 60 595900 Facsimile: +46 60 575250
Contact Person: Ivan Fernandez, Director of Regulatory Compliance
E-mail address: Ivan.Fernandez@permobil.com
Telephone number: 800-736-0925
Date Prepared: June, 2019
Trade name: F5 Corpus VS
Common or Usual Name: Powered wheelchair, Standup
Classification Name: Standup Wheelchair
Primary Product Code (Standup feature): IPL
Secondary Product Code: ITI
Predicate Device:
Primary: Quickie® Q700-UP M (K172384) manufactured by Sunrise Medical (US) LLC Secondary: F5 (K143014) manufactured by Permobil AB.
Description of the F5 Corpus VS:
This submission covers the F5 Corpus VS device.
Indications for use:
The F5 Corpus VS powered wheelchair is to provide indoor mobility, including stand-up feature, to persons limited to a seating position that are capable of operating a powered wheelchair.
Environment of Use:
This wheelchair has been designed to accommodate both indoor use at care facilities and private residences. The chair is capable of handling different surfaces but performs optimally on firm even surfaces such as concrete, asphalt and indoor flooring. The Chair is designed to
-overcome a maximum obstacle height of 3" (not in standing mode), -operate at a maximum incline angle for safe operation of 9°,
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Image /page/4/Picture/1 description: The image shows the Permobil logo. The word "permobil" is written in blue, with the "o" in "mobil" stylized as a circle. Below the word "permobil" is the phrase "THE POWER OF MOBILITY" in a smaller, sans-serif font.
-Travel a maximum distance of 16 miles on fully charged battery.
Principles of Operation:
F5 Corpus VS Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick.
The F5 Corpus VS is powered by two 12VDC, Group M24, approximate driving range on fully charged batteries is up to 25km (15.5 miles), depending on use and the terrain the chair is driven on. The chair frame is a steel construction and includes two front drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's 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 chair is allowed to move in 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 to stop by letting go of the joystick.
F5 Corpus VS will enable the user to stand up, completely or partially, to facilitate reaching, working eye to eye with colleagues.
The standing sequence is controlled by the joystick and gives the user the possibility to come to a standing position. The seating, chest support and knee stop stabilize the user during the stand-up or sitdown operation.
Comparison to Predicate Devices:
The following tables provides a comparison of the predicate device Q700-UP M and the F5 Corpus VS to demonstrate substantial equivalence. F5 Corpus VS has the same general intended use and similar indications, principles of operation, and similar technological characteristics as the previously cleared predicate Ouickie® O700-UP M. The functional difference is small and do not present any new issues of safety or effectiveness because both wheelchairs pass the requirements in ISO 7176. Thus, the F5 Corpus VS is substantially equivalent to the Q700-UP M.
| Use/functions/characteristics | Primary Predicate device | Submitted device |
|---|---|---|
| Quickie® Q700-UP M | F5 Corpus VS | |
| (K172384)(Data collected from | ||
| 510(k) summary) | ||
| Intended use | The Sunrise Medical Quickie® | The F5 Corpus VS powered |
| Q700-UP M power wheelchairs are | wheelchair is to provide indoor and | |
| battery operated devices, that are | outdoor mobility, including stand-up | |
| indicated for medical purposes to | feature, to persons limited to a | |
| provide mobility and repositioning | seating position that are capable of | |
| of the user, including a stand-up | seating position that are capable of | |
| feature. | operating a powered wheelchair | |
| Type of base | Mid wheel driven | Front wheel driven |
| Type of motors | 6.0 mph Motor Package Output | LINIX 24V PM 500W |
| Speed: 163 rpm | ||
| Gear Ratio: 26:1 | ||
| Peak Power: 1026W @120A | ||
| 8.0 mph Motor Package: | ||
| Output speed: 220 rpm |
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Image /page/5/Picture/1 description: The image shows the logo for Permobil. The word "permobil" is written in a sans-serif font in blue. Below the word "permobil" is the phrase "THE POWER OF MOBILITY" in a smaller, sans-serif font, also in blue. The logo is simple and modern.
| Gear Ratio: 26:1Peak Power: 1293W @120A | ||
|---|---|---|
| Electronics | PG R-Net 120Amp | PG R-Net PM 120 120Amp |
| Battery | 2 X 12V Group 24 - 73Ahr2 X 12V Group 34 -50 Ahr | 2 x 12V 73 Ah gel Group M24 |
| Drive wheel dimension | 14" diameter | 3.00"-8" |
| Rear wheel dimension | 6" diameter | 210x65 (8"x2,5") |
| Adjustable Support Wheels | Mid wheel driven | Support Wheels mounted in thefront, R100x32(4"x0.1,26") |
| Over all dimension, 1/w/h in mm | 36"/25"/not stated" | 1140/790/1170(45"/31"/46") |
| Weight incl. batteries | 375 lbs | 191 kg (421 lbs)(incl. Corpus VSSeat and elevator, seat tilt) |
| Weight bearing capacity | 265 Ibs | 136 kg (300 lbs) |
| Maximum speed | 6 or 8 mph | Up to 12 km/h (7,5 mph) |
| Turning Radius | 43" (Turning circle) | 762,5 mm (30") |
| Driving range | 21 miles (55 Ahr Batteries) | Up to 25 km (16 miles) |
Comparison to Secondary Predicate Device:
The F5 Corpus VS is substantially equivalent to the F5 (#K143014). The F5 Corpus VS has the same intended uses and similar indications, technological characteristics and principles of operation. F5 Corpus VS has the same option in tilt, recline and elevation functions as the reference device, see table below. These functions working in the same technological characteristics as the F5.
| Use/functions/characteristics | Secondary Predicate deviceF5 (K143014) | Submitted deviceF5 Corpus VS |
|---|---|---|
| Intended use | To provide indoor and outdoormobility to persons restricted to asitting position that are capable ofoperating a powered wheelchair | To provide indoor and outdoormobility, including a Stand-upfeature, to persons restricted to asitting position that are capable ofoperating a powered wheelchair |
| Type of base | Front wheel driven | Front wheel driven |
| Type of motors | LINIX 24V PM 230W | LINIX 24V PM 500W |
| Electronics | PG R-Net PM 120 120 Amp | Electronics PG R-Net PM 120 120Amp |
| Type of brakes | Electronic braking by drive motor.Magnetic parking brakes | Electronic braking by drive motor.Magnetic parking brakes |
| Battery | 2 x 12V 73 Ah gel Group M24 | 2 x 12V 73 Ah gel Group M24 |
| Drive wheel dimension | 3.00"- 8" | 3.00"- 8" |
| Rear wheel dimension | 210 x 65 mm (8.3" x 3") | 210 x 65 (8" x 2.5") |
| Adjustable Support Wheels | Support Wheels mounted in thefront, R100x24 (4" x 0.9") | Support Wheels mounted in thefront, R100x32 (4" x 0.9") |
| Over all dimension,length/width/height in mm | 1140/680/820 | 1980/820/875 |
| Weight incl. batteries | 186 kg (410 lbs)( with M24batteries) | 191 kg (421 lbs)(incl. Corpus VSSeat and elevator, seat tilt) |
| Weight bearing capacity | 136 kg (300 lbs) | 136 kg (300 lbs) |
| Maximum speed | 12 km/hr (7.6 mph) | Up to 12 km/h (7,5 mph) |
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ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: F5 CORPUS VS
Image /page/6/Picture/1 description: The image shows the Permobil logo. The word "permobil" is written in a blue, sans-serif font. Below the word "permobil" is the phrase "THE POWER OF MOBILITY" in a smaller, black, sans-serif font. The logo is simple and modern.
| 4.4 km/hr (3 mph)-rev | ||
|---|---|---|
| Brake system | Multiple brake system:1. Electronic braking by drivemotors.2. Magnetic parking brakes thatautomatically stops the chair in caseof power failure. | Multiple brake system:1. Electronic braking by drivemotors.2. Magnetic parking brakes thatautomatically stops the chair in caseof power failure. |
| Ground clearance/Obstacle-climbing | 76 mm/75 mm (3"/3") | 76 mm/75 mm (3"/3") |
| Turning Radius | 762,5 mm (30") | 762,5 mm (30") |
| Driving range | Up to 25 km (15.5 miles) | Up to 25 km (16 miles) |
| EMI (ElectromagneticInterference) | 20V/m modulated 80% AM | 20V/m modulated 80% AM |
| Seat width | 480 mm | 470 mm |
| Total width | 620 mm (24.5") | 25.5-31" |
| Total length | 1256 mm (49.5") | 44.8" |
| Seat plate depth | Not provided | 14-22" |
| Armrest height | 235 mm | 180 mm |
| Turning circle | 762.5 mm | 1470 mm |
| Speed | Up to 12 km/hr (7.5 mph) | 12.20 km/hr (7.5 mph fwd)4.4 km/hr (3 mph rev) |
| Range | 23.79 km | 16 miles (25 km) |
| Manageable gradient | 6° | 9° |
| Max curb height | 60 mm | 3" |
| Max user weight | 150 kg | 300 lbs. (136 kg) |
| Transport volume max | 655-790 mm (w) x 825-930 mm (l)x 825 mm (h) | 36.5" x 31" x 32.5" |
| Joystick Mounting | Not provided | Not provided |
| Attendant Controls | N/A | N/A |
| Light kit option | Not provided | Not provided |
The minor technological differences between the F5 Corpus VS and its Reference device F5 raise no new issues of safety or effectiveness. Performance data demonstrates that the F5 Corpus VS is as safe and effective as the F5. Thus, the F5 Corpus VS is substantially equivalent.
Non-Clinical Testing:
The F5 Corpus VS complies to the below standards:
| Standard # as tested | Title |
|---|---|
| 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 |
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ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: F5 CORPUS VS
Image /page/7/Picture/1 description: The image shows the Permobil logo. The word "permobil" is written in a bold, sans-serif font in blue color. Below the word "permobil" is the tagline "THE POWER OF MOBILITY" in a smaller, sans-serif font, also in blue.
| ISO 7176-4:2008 | Energy consumption of electric wheelchairs and scooters for determinationof theoretical distance range |
|---|---|
| ISO 7176-5:2008 | Determination of overall dimensions, mass and maneuvering space |
| ISO 7176-6:2001 | Determination of maximum speed, acceleration and deceleration of electricwheelchairs |
| ISO 7176-7:1998 | 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 electric wheelchairs |
| ISO 7176-10:2008 | Determination of obstacle-climbing ability of electrically poweredwheelchairs |
| ISO 7176-11:2012 | Test dummies |
| ISO 7176-13:1989 | Determination of coefficient of friction of test surfaces |
| ISO 7176-14:2008 | Power and control systems for electrically powered wheelchairs and scooters- requirements and test methods |
| ISO 7176-15:1996 | Requirements for information disclosure, documentation and labelling |
| ISO 7176-16:2012 | Resistance to ignition of postural support devices |
| ISO 7176-19:2008 | Wheeled mobility devices for use as seats in motor vehicles |
| ISO 7176-21:2009 | Requirements and test methods for electromagnetic compatibility ofelectrically powered wheelchairs and scooters, and battery chargers |
| ISO 7176-22:2014 | Set-up procedures |
| ISO 7176-25:2013 | Batteries and chargers for powered wheelchairs |
| ISO 7176-26:2007 | Vocabulary |
| RESNA WC-1:2009Section 20 | Determination of the Performance of Stand-up Type Wheelchairs |
Clinical Testing:
Clinical testing is not applicable.
Conclusions:
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device. The F5 Corpus VS and Predicate device Q700-UP M are substantially equivalent. The F5 Corpus VS and Secondary predicate device F5 are substantially equivalent. F5 Corpus VS has the same general intended use and similar indications, principles of operation, and similar technological characteristics as the previously cleared Q700-UP M and F5 (K143014).
§ 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).