F5 Corpus VS

K191874 · Permobil AB · IPL · Oct 25, 2019 · Physical Medicine

Device Facts

• Record ID: K191874
• Device Name: F5 Corpus VS
• Applicant: Permobil AB
• Product Code: IPL · Physical Medicine
• Decision Date: Oct 25, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3900
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

F5 Corpus VS is a battery-powered, front-wheel-drive powered wheelchair. User operates device via joystick interface connected to an R-net 120 amp controller. Joystick input signals controller to release solenoid electromechanical brakes for movement; releasing joystick triggers automatic braking. Device features integrated stand-up functionality, allowing users to transition to full or partial standing positions to facilitate reaching or eye-level interaction. Seating, chest support, and knee stop components stabilize user during standing/sitting sequences. Designed for use in private residences and care facilities on firm, even surfaces. Provides mobility, postural support, and functional independence for users with limited mobility.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing, including compliance with ISO 7176 standards (stability, braking, energy consumption, dimensions, speed, fatigue strength, climatic tests, obstacle climbing, and electromagnetic compatibility) and RESNA WC-1:2009 Section 20.

Technological Characteristics

Steel frame construction; front-wheel drive with LINIX 24V PM 500W motors; PG R-Net PM 120 120Amp controller; two 12V 73Ah gel Group M24 batteries. Features solenoid electromechanical brakes and electronic motor braking. Dimensions: 1140/790/1170 mm. Max speed 12 km/h; max range 25 km. Complies with ISO 7176 series and RESNA WC-1:2009 standards.

Indications for Use

Indicated for persons limited to a seating position who are capable of operating a powered wheelchair, requiring indoor mobility and a stand-up feature.

Regulatory Classification

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.

Predicate Devices

• Quickie® Q700-UP M (K172384)
• F5 (K143014)

Submission Summary (Full Text)

{0}------------------------------------------------

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.

{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 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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="text-decoration: overline;">☒</span> Prescription Use (Part 21 CFR 201. Subpart D) |
|-------------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☒</span> 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)

#### 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 [e-mail]

"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}------------------------------------------------

## 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: [phone] Facsimile: [phone]

Contact Person: Ivan Fernandez, Director of Regulatory Compliance

E-mail address: [e-mail]

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°,

{4}------------------------------------------------

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/<br>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 | |

{5}------------------------------------------------

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: 26:1<br>Peak Power: 1293W @120A | |
|---------------------------------|------------------------------------------------------|-------------------------------------------------------------------|
| Electronics | PG R-Net 120Amp | PG R-Net PM 120 120Amp |
| Battery | 2 X 12V Group 24 - 73Ahr<br>2 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 the<br>front, 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 VS<br>Seat 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/<br>characteristics | Secondary Predicate device<br>F5 (K143014) | Submitted device<br>F5 Corpus VS |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | To provide indoor and outdoor<br>mobility to persons restricted to a<br>sitting position that are capable of<br>operating a powered wheelchair | To provide indoor and outdoor<br>mobility, including a Stand-up<br>feature, to persons restricted to a<br>sitting position that are capable of<br>operating 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 120 120<br>Amp |
| Type of brakes | Electronic braking by drive motor.<br>Magnetic parking brakes | Electronic braking by drive motor.<br>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 the<br>front, R100x24 (4" x 0.9") | Support Wheels mounted in the<br>front, R100x32 (4" x 0.9") |
| Over all dimension,<br>length/width/height in mm | 1140/680/820 | 1980/820/875 |
| Weight incl. batteries | 186 kg (410 lbs)( with M24<br>batteries) | 191 kg (421 lbs)(incl. Corpus VS<br>Seat 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) |

{6}------------------------------------------------

# 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:<br>1. Electronic braking by drive<br>motors.<br>2. Magnetic parking brakes that<br>automatically stops the chair in case<br>of power failure. | Multiple brake system:<br>1. Electronic braking by drive<br>motors.<br>2. Magnetic parking brakes that<br>automatically stops the chair in case<br>of power failure. |
| Ground clearance/Obstacle-<br>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 (Electromagnetic<br>Interference) | 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)<br>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)<br>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 |

{7}------------------------------------------------

# 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 determination<br>of 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 electric<br>wheelchairs |
| 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 powered<br>wheelchairs |
| 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<br>- 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 of<br>electrically 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-1:2009<br>Section 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).