e-motion M25

K221215 · Alber GmbH · ITI · May 24, 2022 · Physical Medicine

Device Facts

• Record ID: K221215
• Device Name: e-motion M25
• Applicant: Alber GmbH
• Product Code: ITI · Physical Medicine
• Decision Date: May 24, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The e-motion M25 DuoDrive is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.

Device Story

Power assist conversion kit for manual wheelchairs; converts manual chairs to electric-assist. Input: user force applied to push-rims. Operation: brushless DC motors in wheels provide assistive torque; controlled via push-rims, smartphone app, ECS remote, or detachable control unit. Output: motorized propulsion assistance. Used by active wheelchair users in indoor/outdoor environments. Healthcare provider/dealer selects compatible wheelchair from mounting database. Benefits: increased mobility, flexibility, and reduced physical effort for users. Features include cruise mode, rollback delay, and learner mode. Wireless communication (BLE) between wheels, app, and control units. Safety: automatic shut-off, encrypted wireless, and fail-safe state (no power) if connection lost.

Clinical Evidence

Bench testing only. No clinical data presented. Performance verified against ISO 7176 standards (power, range, gradient, EMC, wireless coexistence).

Technological Characteristics

Power assist conversion kit; brushless DC motors (2x80W); Li-ion battery (36.5V); quick-release axle. Connectivity: IEEE 802.15.4 (BLE/Classic) for app/remote/control unit. Protection: IPx4. Materials: standard wheelchair components. Sterilization: N/A. Software: embedded firmware with wireless interface.

Indications for Use

Indicated for manual wheelchair users with physical conditions limiting their field of activities, requiring assistance with wheelchair operating force.

Regulatory Classification

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.

Predicate Devices

• e-motion M25 (K192618)
• SMOOV 010 (K192016)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Alber GmbH % Michael Vent RA- Consultant BEO MedConsulting Berlin GmbH Helmholtzstr. 2-9 Berlin, 10587 Germany

Re: K221215

Trade/Device Name: e-motion M25 DuoDrive Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: April 11, 2022 Received: April 27, 2022

Dear Michael Vent:

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.

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Neuromodulation & Rehabilitation 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) K221215

Device Name e-motion M25 DuoDrive

Indications for Use (Describe)

The e-motion M25 DuoDrive is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY

Image /page/3/Picture/2 description: The image features the word "alber" in white font against a solid purple background. The font is sans-serif, with a slightly rounded and modern appearance. The word is centrally aligned within the frame, and the purple background fills the entire space behind it.

| Applicant: | Alber GmbH<br>Vor dem Weißen Stein 14<br>72461 Albstadt, Germany<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr Michael Vent<br>Phone: [phone]<br>Email: [e-mail] |
| Device: | Proprietary: e-motion M25 DuoDrive<br>Common Name: Power Assist Conversion Kit for Manual Wheelchairs<br>Classification Name: Powered wheelchair<br>Device Class: II, 21 CFR 890.3860<br>Classification Panel: Physical Medicine<br>Product Code: ITI |
| Predicate Device: | 510(k): K192618<br>Proprietary: e-motion M25<br>Common Name: Power Assist Conversion Kit for Manual Wheelchairs<br>Classification Name: Powered wheelchair<br>Device Class: II, 21 CFR 890.3860<br>Classification Panel: Physical Medicine<br>Product Code: ITI |
| Secondary Predicate Device: | 510(k): K192016<br>Proprietary: SMOOV 010<br>Common Name: add-on drive for wheelchairs<br>Classification Name: Powered wheelchair<br>Device Class: II, 21 CFR 890.3860<br>Classification Panel: Physical Medicine<br>Product Code: ITI |
| | |

#### Preparation Date: 20th May 2022

### Indications for Use:

The e-motion M25 DuoDrive is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.

### Change Information:

The change is a change of our own device, previously cleared in K192618. The e-motion M25 (K192618) was upgraded with a wireless control unit (blutooth rotary wheel, formerly also called blutooth clickwheel) that was cleared with the 510(k) of our own device smoov O10, cleared in 510(k) K192016. The detachable control unit allows access to the driving mode called "cruise mode". This mode already existed in the cleared e-motion M25, but it was only accessible by using the smartphone app.

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Image /page/4/Picture/0 description: The image features a square logo with a solid purple background. In the lower portion of the square, the word "alber" is written in a sans-serif font, with the letters in white. In the upper right corner of the square, there is a circled "R" symbol, indicating a registered trademark.

As the manufacturer of all involved products and components, we made the change under our design control process. In the following, the modified model will be called "e-motion M25 (DuoDrive)" to make it easier to distinguish.

| Comparison of the modified device to the cleared | |
|--------------------------------------------------|--------------------------|
| e-motion M25 (K192618) | e-motion<br>(K192618) |
| Cleared device, material | Cleared device, material |

| e-motion M25 (K192618) | e-motion M25 DuoDrive |
|-----------------------------------------------|--------------------------------------------------------------|
| Cruise mode via smartphone app (K192618) | Cruise mode via smartphone app and control unit<br>(K192016) |
| User manual without control unit instructions | User manual with control unit instructions |

# Device Description:

The e-motion-M25 DuoDrive is a medical device for active wheelchair users who are reliant on a wheelchair as a result of their disability. The subject device e-motion is an additional drive for wheelchairs that is attached to a manual wheelchair, converting it into an electrically driven and thus significantly increasing the wheelchair user's mobility and flexibility.

To extend functionality an optional remote control (ECS) a smartphone app and a detachable control unit is available.

The user interacts with the e-motion M25 DuoDrive via two push-rims that trigger the assistive power drive.

The main parts of the drive unit are as follows:

- Pushrim-wheels including a brushless DC-motor .
- Control electronic for the motor and wireless interface for communication with ECS remote control and smartphone app
- . Integrated lithium ion battery pack with battery management system
- . Magnetic charger socket for the integrated battery (Easy Connect) for connecting the battery charger
- Quick-release axle for attaching and detaching the drive unit to wheelchair-frame ●

The main function of the APP are as follows:

- Status information (battery, speed)
- . Live display of error messages
- Recording of tours ●
- Selection of preset driving profiles ●
- ECS functionality (extra charge, details see below)
- Wheelchair navigation (extra charge) ●
- Enhance maximum speed (extra charge) ●
- . Cruise mode (extra charge)
- Activation flight mode
- System information ●
- Error logfile (password protected) ●
- Setting auto shut-off time (password protected)
- Inidivial adjustment of driving parameters (password protected) ●

The main function of the ECS remote control are as follows:

- Switch between 2 assist level for indooir and outdoor
- Selection of learner mode (formerly also called Training mode) ●
- Activation of rollback delay (hill holder) ●
- Switch the wheels on and off (standby mode) ●

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Image /page/5/Picture/18 description: The image shows the logo for the Dutch supermarket chain, "albert heijn". The logo consists of the word "albert" in lowercase, sans-serif font, with the letters in white. The word is set against a solid purple square background. The logo is simple and modern.

The main parts of the control unit are as follows:

- . Wireless interface for communicating with the drive wheels
- Rotary wheel to start and change the cruise speed .
- Rotary wheel to stop cruise mode (short push on the side) .
- Rotary wheel to switch the drive wheels on and off/standy mode (long push on the side)
- Integrated Li-ion battery cell including battery management system ●
- USB-C socket for charging via drive unit or other external USB-C charger
- Display for operating status and remaining capacity of drive wheels and control unit ●

To charge the battery of the drive unit a battery charger is available. Main attributes:

- Multi-range charger 100-240 VAC, 50-60 Hz .
- Automatic charging and switch-off mechanism .
- Indicating status and mains ●

#### Power Wheel Range: up to 25 km as per ISO 7176 - 4 Nominal gradient: 16% [9°] - also note the limit values specified by the wheelchair manufacturer. Maximum downhill grade: Depends on the user and weight of the wheelchair. Also note the limit values specified by the wheelchair manufacturer Cornering radius (minimum): the limit values specified by the wheelchair manufacturer Maximum speed: Standard: 6 km/h to 8.5 km/h Rated power of engine: 2x80W Operating voltage: 36.5 VDC -25° C to +50° C Operating temperature: Storage temperature: -40° C to +65° C Weight of person: max. 150 kg Max. permissible overall weight: 180 kg Protection rating: IPx4 Battery pack Lithium-ion 10ICR19/66-2 Cell type: Rated operating capacity: 36.5 V Rated capacity: Ah Rated energy: Wh Charging temperature: 0° C to +45° C -25° C to +50° C Operating temperature: IPX4 Protection rating: ECS remote control Cell type: AAA Rated voltage: 3x1.5 VDC Rated capacity: 750 ... 1000mAh Control unit Cell ty n 18650

| Cell type: | Lithium-io |
|-----------------|------------|
| Rated voltage: | 3.6 VDC |
| Rated capacity: | 2.6 Ah |
| Rated energy: | 9.36W |

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Image /page/6/Picture/0 description: The image features the word "alber" in white font against a solid purple background. The word is written in lowercase letters, with a modern and slightly rounded sans-serif typeface. The purple background is a uniform color, providing a strong contrast to the white text, making it easily readable.

Charging temperature: Operating temperature:

### Charger

| Model: | PS 4820 |
|----------------------|---------------------------|
| Mains voltage: | 100...240 VAC, 50...60 Hz |
| Power output: | 96 W |
| Output voltage: | 2x48 VDC |
| Output current: | 2x1.0 A |
| Protection rating: | IP 31 |
| Ambient temperature: | Operation 0...40 °C |
| Storage | -40...+65 °C |
| Humidity: | Operation 10...80% |
| Storage | 5...95% |
| Air pressure: | Operation 500...1060 hPa |
| Storage | 700...1060 hPa |

### Weight of components

| Wheel (including battery): | 7.8 kg |
|-----------------------------------------|---------|
| ECS remote control (including battery): | 0.25 kg |
| Control unit (including battery) | 0.25 kg |
| Battery charger: | 1.2 kg |
| Total weight: | 15.6 kg |

### Radio Frequency Wireless Technology

Power Unit Type of wireless technology FCC compliance: FCC ID: Wireless Coexistence Compliance: EMC compliance RF frequency range: RF maximum output power: Wireless operating range: Wireless functions:

EEE 802.15.4 (BLE & Classic) CFR47, Part 15 A8TBM78ABCDEFGH ANSI C63.27-2017, separation distance >0.25m ISO 7176-21:2009 2.402 GHz to 2.480 GHz 1.5dBm 10m / class 2 Speed, emergency stop, operating mode (on/standby)

ECS remote control Type of wireless technology: FCC compliance: FCC ID: Wireless Coexistence Compliance: EMC compliance: Wireless RF frequency range: Wireless RF maximum output power: Wireless operating range: Wireless functions:

Control Unit Type of wireless technology: FCC compliance: FCC ID: Wireless Coexistence Compliance: IEEE 802.15.4 (Bluetooth Low Energy) CFR47, Part 15 ZAT26M1 ANSI C63.27-2017, separation distance ≥0.25m ISO 7176-21:2009 2.402 GHz to 2.480 GHz 5dBm 10m / class 2 Speed, emergency stop, operating mode (on/standby)

IEEE 802.15.4 (Bluetooth Low Energy) CFR47, Part 15 ZAT26M1 ANSI C63.27-2017, separation distance ≥0.25m

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Image /page/7/Picture/0 description: The image shows the logo for Alber. The logo consists of a purple square with the word "alber" in white letters. The "e" in "alber" is stylized with a curved line extending from the top of the "e" to the bottom. There is a registered trademark symbol in the upper right corner of the square.

EMC compliance: Wireless RF frequency range: Wireless RF maximum output power: Wireless operating range: Wireless functions:

ISO 7176-21:2009 2.402 GHz to 2.480 GHz 5dBm 10m / class 2 Speed, emergency stop, operating mode (on/standby)

# Cybersecurity assessment/mitigation, including SweynTooth vulnerabilities evaluation

SweynTooth affects the wireless communication technology known as Bluetooth Low Energy (BLE). BLE allows two devices to "pair" and exchange information to perform their intended functions while preserving battery life. The technology can be found in medical devices as well as other devices, such as consumer wearables. SweynTooth may allow an unauthorized user to wirelessly crash the device (crash), stop it from working (deadlock), or access device functions normally only available to the authorized user (bypass security).

These vulnerabilities cannot be exploited remotely, and all of these attacks require that the device Bluetooth is enabled and that the attacker is within close physical proximity (i.e., within Bluetooth range) of the device.

Our preventive actions to avoid harm: All wireless communication is encrypted.

In the unlikely event a successful attack, the e-motion M25 DuoDrive:

- Normal drive mode - An attack during this mode has no influence on driving behaviour as the e-motion M25 (DuoDrive) acts in this mode independent from any wireless devices.
- . Cruise Mode - The motor driving support stops in order to enter the safe state of the system (-no more auxiliary power provision). Unintended movements are impossible. In any cases the connection is lost; you are always able to react to avoid dangerous situations by moving away from the danger zone by propelling the system like an e-motion M25 DuoDrive in the normal drive mode.
- Remote Mode (Wheelchair is un-occupied see App instruction for use): The motor driving ● support stops in order to enter the safe state of the system (=no more auxiliary power provision). Unintended movements are impossible.

| | SUBJECT DEVICE<br>e-motion M25<br>DuoDrive | PREDICATE DEVICE<br>e-motion M25<br>(K192618) | SECONDARY<br>PREDICATE DEVICE<br>SMOOV O10<br>(K192016) |
|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication For Use | The e-motion M25 is a Power<br>Assist Wheelchair Conversion<br>Kit and suitable for the manual<br>wheelchair users who are<br>limited in their field of activities<br>because of their physical<br>conditions. The device can<br>expand their field of activities<br>by assisting their wheelchair<br>operating force. | The e-motion M25 is a Power<br>Assist Wheelchair Conversion<br>Kit and suitable for the manual<br>wheelchair users who are<br>limited in their field of activities<br>because of their physical<br>conditions. The device can<br>expand their field of activities<br>by assisting their wheelchair<br>operating force. | The "SMOOV" add-on drive for<br>wheelchairs is intended to<br>provide auxiliary power to<br>manual wheelchairs to reduce<br>the pushing power needed by<br>their users. It is designed to<br>provide support to active<br>wheelchair users who are<br>physically and mentally able to<br>safely control a manual<br>wheelchair in typical situations,<br>including inclines, even<br>manually. |
| Intended Use | The e-motion M25 is a medical<br>device for active wheelchair<br>users who are reliant on a<br>wheelchair as a result of their<br>disability. | The e-motion M25 is a medical<br>device for active wheelchair<br>users with a user weight of 150<br>kgs and who are reliant on a<br>wheelchair as a result of their | The SMOOV is a medical<br>device for active wheelchair<br>users who are reliant on a<br>wheelchair as a result of their<br>disability. The SMOOV is an |
| | | | |
| | The e-motion M25 replaces the<br>wheels that are attached to a<br>manual wheelchair, converting<br>it into an electrically driven<br>wheelchair and thus<br>significantly increasing the<br>wheelchair user's mobility and<br>flexibility.<br>The e-motion M25 must always<br>be used, transported, maintained<br>and serviced strictly according<br>to the manufacturer's<br>instructions. The e-motion M25<br>must only be attached to and<br>operated with wheelchairs that<br>are listed in Alber's mounting<br>database.<br>The selection is made by the<br>specialist dealer or by Alber<br>itself. | disability.<br>The e-motion M25 replaces the<br>wheels that are attached to a<br>manual wheelchair, converting<br>it into an electrically driven<br>wheelchair and thus<br>significantly increasing the<br>wheelchair user's mobility and<br>flexibility.<br>The e-motion M25 must always<br>be used, transported, maintained<br>and serviced strictly according<br>to the manufacturer's<br>instructions. The e-motion M25<br>must only be attached to and<br>operated with wheelchairs that<br>are listed in Alber's mounting<br>database. The selection is made<br>by the specialist dealer or by<br>Alber itself. | add-on drive for wheelchairs<br>that is attached to a manual<br>wheelchair, converting it into an<br>electrically driven wheelchair<br>and thus significantly<br>increasing the wheelchair user's<br>mobility and flexibility.<br>The SMOOV must always be<br>used, transported, maintained<br>and serviced as described in the<br>operating manual. The SMOOV<br>must only be attached to and<br>operated with wheelchairs that<br>are listed in Alber's mounting<br>database.<br>The selection is made by the<br>specialist dealer or by Alber<br>itself. |
| Permissible conditions<br>of use/locations of<br>operation<br>Type Environment of<br>Use | • Observe the permissible<br>conditions of use of the<br>wheelchair to which the e-<br>motion M25 (DuoDrive) is<br>attached.<br>• In addition to observing the<br>information provided about<br>the e-motion M25<br>(DuoDrive), it is also<br>imperative to observe the<br>information provided by the<br>wheelchair manufacturer<br>(e.g. maximum gradeability,<br>maximum permissible height<br>of obstacles, maximum user<br>weight, maximum speed,<br>etc.). The lowest values<br>always apply.<br>• Any limits regarding the<br>operation of your wheelchair<br>(e.g. maximum gradeability,<br>maximum permissible height<br>of obstacles, maximum user<br>weight etc.) must also be<br>observed when using the<br>M25.<br>• The e-motion M25<br>(DuoDrive) must only be<br>operated at temperatures<br>between -25 °C and +50 °C.<br>Therefore, do not expose the<br>smoov to any heat sources<br>(such as intense sunlight) as<br>this may cause surfaces to<br>reach high temperatures.<br>• The e-motion M25<br>(DuoDrive) is designed for<br>indoor and outdoor use (e.g.<br>solid pavement), avoid using<br>the wheelchair on soft<br>ground (e.g. loose chipping,<br>sand, mud, snow, ice or deep<br>puddles). | • Observe the permissible<br>conditions of use of the<br>wheelchair to which the M25<br>is attached.<br>• In addition to observing the<br>information provided about<br>the M25, it is also imperative<br>to observe the information<br>provided by the wheelchair<br>manufacturer (e.g. maximum<br>gradeability, maximum<br>permissible height of<br>obstacles, maximum user<br>weight, maximum speed,<br>etc.). The lowest values<br>always apply.<br>• Any limits regarding the<br>operation of your wheelchair<br>(e.g. maximum gradeability,<br>maximum permissible height<br>of obstacles, maximum user<br>weight etc.) must also be<br>observed when using the<br>M25.<br>• The e-motion M25 must<br>only be operated at<br>temperatures between -25 °C<br>and +50 °C. Therefore, do<br>not expose the smoov to any<br>heat sources (such as intense<br>sunlight) as this may cause<br>surfaces to reach high<br>temperatures.<br>• The e-motion M25 is<br>designed for indoor and<br>outdoor use (e.g. solid<br>pavement), avoid using the<br>wheelchair on soft ground<br>(e.g. loose chipping, sand,<br>mud, snow, ice or deep<br>puddles). | • Observe the permissible<br>conditions of use of the<br>wheelchair to which the<br>smoov is attached.<br>• In addition to observing the<br>information provided about<br>the smoov, it is also<br>imperative to observe the<br>information provided by the<br>wheelchair manufacturer<br>(e.g. maximum gradeability,<br>maximum permissible height<br>of obstacles, maximum user<br>weight, maximum speed,<br>etc.). The lowest values<br>always apply.<br>• Any limits regarding the<br>operation of your wheelchair<br>(e.g. maximum gradeability,<br>maximum permissible height<br>of obstacles, maximum user<br>weight etc.) must also be<br>observed when using the<br>SMOOV.<br>• The SMOOV O10 must only<br>be operated at temperatures<br>between -25 °C and +50 °C.<br>Therefore, do not expose the<br>smoov to any heat sources<br>(such as intense sunlight) as<br>this may cause surfaces to<br>reach high temperatures.<br>• The SMOOV O10 is<br>designed for light outdoor<br>use (e.g. solid pavement),<br>avoid using the wheelchair<br>on soft ground (e.g. loose<br>chipping, sand, mud, snow,<br>ice or deep puddles). |

# Comparison to the Predicate Device

D-72461 Albstadt

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Image /page/8/Picture/1 description: The image is a square logo for Alber. The background is a solid purple color. The word "alber" is written in white, lowercase letters in the center of the square. The font is sans-serif and the letters are slightly rounded. A registered trademark symbol is located in the upper right corner of the square.

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Image /page/9/Picture/0 description: The image shows the logo for Alber. The logo consists of the word "alber" in white font on a purple background. The font is sans-serif and appears to be bolded. The logo is simple and modern.

| Market Segment | Active | Active | Active |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wheelchair<br>Compatibility | manually propelled wheelchairs with rigis or folding frames Quick-release-axle | manually propelled wheelchairs with rigis or folding frames Quick-release-axle | Rigid W/C frames: Universal brackets on the axle tube Folding frames: adapter axle required |
| Available Wheelchair<br>Wheel-Diameters<br>(inch) | 22", 24", 25" | 22", 24", 25" | Compatible with wheel diameter 22" - 26" |
| Device Wheel<br>Dimensions (inch) | 22", 24", 25" | 22", 24", 25" | Diameter: 6.4"<br>Width: 3,9" |
| Max. user weight (kg) | 150kg | 150kg | 140 |
| System weight (kg) | 15.85kg | 15.6kg | 7,95kg |
| Nominal Power (Watt) | 2x80W | 2x80W | 250W |
| Max. assisted Speed<br>(km/h) | 6...8.5km/h | 6...8.5km/h | 6 / 10km/h |
| Nominal Range (km) | 25km | 25km | 20km |
| Assist Levels | Push-force support | Push-force support | Speed adjustments stepless via<br>clickwheel |
| Control Units | Pushrims & ECS remote control<br>& smartphone app & Control<br>unit attached to W/C | Pushrims & ECS remote control<br>& smartphone app | Control unit = Bluetooth<br>clickwheel attached to W/C |
| Adjustment of drive<br>parameters | Acceleration in 2 modes:<br>indoor, outdoor, learner mode | Acceleration in 2 modes:<br>indoor, outdoor, learner mode<br>(formerly also called Training<br>mode) | acceleration and speed<br>depending on the angle of the<br>drive wheel, 4 programmable<br>driving modes. STOP<br>pushbutton |
| Smartphone App &<br>ECS & Control unitfor<br>end user | App Cockpit (drive-, tour-data) Navigation Drive-Mode (Cruise/Speed) Remote ECS (find below) ECS Pairing Reset Assist level (indoor / outdoor) Learner mode Roll-Back-Prevention Sleep-Mode Control unit Pairing Reset Turn on/off | App Cockpit (drive-, tour-data) Navigation Drive-Mode (Cruise/Speed) Remote ECS (find below) ECS Pairing Reset Assist level (indoor / outdoor) Learner mode (formerly also called Training mode) Roll-Back-Prevention Sleep-Mode | App<br>Android and iOS<br>Free features:<br>Cockpit, battery capacity, range,<br>tour computer via GPS, 4<br>programmable driving modes,<br>On/Off rear light, worldwide<br>service contact details, firmware<br>updates over the air, failure and<br>warnings<br>chargeable: Navigation<br>Control unit Pairing Reset Turn on/off |

{10}------------------------------------------------

8

# K221215

## Conclusion:

The conclusions drawn from the nonclinical tests including a benefit-risk assessment demonstrate that the changed device is as safe, as effective, and performs as well as the legally marketed predicate device.