(27 days)
Not Found
No
The description focuses on electromechanical assistance, control electronics, and user interface features, with no mention of AI or ML algorithms for control, analysis, or adaptation.
No
The device is a power assist wheelchair conversion kit designed to increase mobility and flexibility for wheelchair users, not to treat or cure a medical condition.
No
The device is a power assist wheelchair conversion kit designed to assist manual wheelchair users with mobility, not to diagnose medical conditions.
No
The device is a Power Assist Wheelchair Conversion Kit that includes significant hardware components such as pushrim-wheels with motors, control electronics, batteries, and a quick-release axle, in addition to software components like a smartphone app and remote control.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Power Assist Wheelchair Conversion Kit" to assist manual wheelchair users with their mobility. This is a mechanical and electrical assistance device, not a diagnostic tool.
- Device Description: The description details the components and functions related to providing power assistance for wheelchair propulsion (motors, batteries, controls, app for status and settings). There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The device is clearly intended to enhance mobility for individuals with physical limitations, which falls under the category of a medical device for rehabilitation or assistance, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ITI
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) ●
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/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
1
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,
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
2
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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3
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
Vor dem Weißen Stein 14
72461 Albstadt, Germany
Phone: +49 7432 2006-0
Fax: +49 7432 2006-299
Email: info@alber.de |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr Michael Vent
Phone: +49 30 318 045 30
Email: m.vent@beoberlin.de |
| Device: | Proprietary: e-motion M25 DuoDrive
Common Name: Power Assist Conversion Kit for Manual Wheelchairs
Classification Name: Powered wheelchair
Device Class: II, 21 CFR 890.3860
Classification Panel: Physical Medicine
Product Code: ITI |
| Predicate Device: | 510(k): K192618
Proprietary: e-motion M25
Common Name: Power Assist Conversion Kit for Manual Wheelchairs
Classification Name: Powered wheelchair
Device Class: II, 21 CFR 890.3860
Classification Panel: Physical Medicine
Product Code: ITI |
| Secondary Predicate Device: | 510(k): K192016
Proprietary: SMOOV 010
Common Name: add-on drive for wheelchairs
Classification Name: Powered wheelchair
Device Class: II, 21 CFR 890.3860
Classification Panel: Physical Medicine
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.
4
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 |
| (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 |
| (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) ●
5
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 |
6
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
7
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
e-motion M25
DuoDrive | PREDICATE DEVICE
e-motion M25
(K192618) | SECONDARY
PREDICATE DEVICE
SMOOV O10
(K192016) |
|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication For Use | The e-motion M25 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. | The e-motion M25 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. | The "SMOOV" add-on drive for
wheelchairs is intended to
provide auxiliary power to
manual wheelchairs to reduce
the pushing power needed by
their users. It is designed to
provide support to active
wheelchair users who are
physically and mentally able to
safely control a manual
wheelchair in typical situations,
including inclines, even
manually. |
| Intended Use | The e-motion M25 is a medical
device for active wheelchair
users who are reliant on a
wheelchair as a result of their
disability. | The e-motion M25 is a medical
device for active wheelchair
users with a user weight of 150
kgs and who are reliant on a
wheelchair as a result of their | The SMOOV is a medical
device for active wheelchair
users who are reliant on a
wheelchair as a result of their
disability. The SMOOV is an |
| | | | |
| | The e-motion M25 replaces the
wheels that are attached to a
manual wheelchair, converting
it into an electrically driven
wheelchair and thus
significantly increasing the
wheelchair user's mobility and
flexibility.
The e-motion M25 must always
be used, transported, maintained
and serviced strictly according
to the manufacturer's
instructions. The e-motion M25
must only be attached to and
operated with wheelchairs that
are listed in Alber's mounting
database.
The selection is made by the
specialist dealer or by Alber
itself. | disability.
The e-motion M25 replaces the
wheels that are attached to a
manual wheelchair, converting
it into an electrically driven
wheelchair and thus
significantly increasing the
wheelchair user's mobility and
flexibility.
The e-motion M25 must always
be used, transported, maintained
and serviced strictly according
to the manufacturer's
instructions. The e-motion M25
must only be attached to and
operated with wheelchairs that
are listed in Alber's mounting
database. The selection is made
by the specialist dealer or by
Alber itself. | add-on drive for wheelchairs
that is attached to a manual
wheelchair, converting it into an
electrically driven wheelchair
and thus significantly
increasing the wheelchair user's
mobility and flexibility.
The SMOOV must always be
used, transported, maintained
and serviced as described in the
operating manual. The SMOOV
must only be attached to and
operated with wheelchairs that
are listed in Alber's mounting
database.
The selection is made by the
specialist dealer or by Alber
itself. |
| Permissible conditions
of use/locations of
operation
Type Environment of
Use | • Observe the permissible
conditions of use of the
wheelchair to which the e-
motion M25 (DuoDrive) is
attached.
• In addition to observing the
information provided about
the e-motion M25
(DuoDrive), it is also
imperative to observe the
information provided by the
wheelchair manufacturer
(e.g. maximum gradeability,
maximum permissible height
of obstacles, maximum user
weight, maximum speed,
etc.). The lowest values
always apply.
• Any limits regarding the
operation of your wheelchair
(e.g. maximum gradeability,
maximum permissible height
of obstacles, maximum user
weight etc.) must also be
observed when using the
M25.
• The e-motion M25
(DuoDrive) must only be
operated at temperatures
between -25 °C and +50 °C.
Therefore, do not expose the
smoov to any heat sources
(such as intense sunlight) as
this may cause surfaces to
reach high temperatures.
• The e-motion M25
(DuoDrive) is designed for
indoor and outdoor use (e.g.
solid pavement), avoid using
the wheelchair on soft
ground (e.g. loose chipping,
sand, mud, snow, ice or deep
puddles). | • Observe the permissible
conditions of use of the
wheelchair to which the M25
is attached.
• In addition to observing the
information provided about
the M25, it is also imperative
to observe the information
provided by the wheelchair
manufacturer (e.g. maximum
gradeability, maximum
permissible height of
obstacles, maximum user
weight, maximum speed,
etc.). The lowest values
always apply.
• Any limits regarding the
operation of your wheelchair
(e.g. maximum gradeability,
maximum permissible height
of obstacles, maximum user
weight etc.) must also be
observed when using the
M25.
• The e-motion M25 must
only be operated at
temperatures between -25 °C
and +50 °C. Therefore, do
not expose the smoov to any
heat sources (such as intense
sunlight) as this may cause
surfaces to reach high
temperatures.
• The e-motion M25 is
designed for indoor and
outdoor use (e.g. solid
pavement), avoid using the
wheelchair on soft ground
(e.g. loose chipping, sand,
mud, snow, ice or deep
puddles). | • Observe the permissible
conditions of use of the
wheelchair to which the
smoov is attached.
• In addition to observing the
information provided about
the smoov, it is also
imperative to observe the
information provided by the
wheelchair manufacturer
(e.g. maximum gradeability,
maximum permissible height
of obstacles, maximum user
weight, maximum speed,
etc.). The lowest values
always apply.
• Any limits regarding the
operation of your wheelchair
(e.g. maximum gradeability,
maximum permissible height
of obstacles, maximum user
weight etc.) must also be
observed when using the
SMOOV.
• The SMOOV O10 must only
be operated at temperatures
between -25 °C and +50 °C.
Therefore, do not expose the
smoov to any heat sources
(such as intense sunlight) as
this may cause surfaces to
reach high temperatures.
• The SMOOV O10 is
designed for light outdoor
use (e.g. solid pavement),
avoid using the wheelchair
on soft ground (e.g. loose
chipping, sand, mud, snow,
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 | |||
| 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 | |||
| Wheel-Diameters | |||
| (inch) | 22", 24", 25" | 22", 24", 25" | Compatible with wheel diameter 22" - 26" |
| Device Wheel | |||
| Dimensions (inch) | 22", 24", 25" | 22", 24", 25" | Diameter: 6.4" |
| 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 | |||
| (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 |
| clickwheel | |||
| Control Units | Pushrims & ECS remote control | ||
| & smartphone app & Control | |||
| unit attached to W/C | Pushrims & ECS remote control | ||
| & smartphone app | Control unit = Bluetooth | ||
| clickwheel attached to W/C | |||
| Adjustment of drive | |||
| parameters | Acceleration in 2 modes: | ||
| indoor, outdoor, learner mode | Acceleration in 2 modes: | ||
| indoor, outdoor, learner mode | |||
| (formerly also called Training | |||
| mode) | acceleration and speed | ||
| depending on the angle of the | |||
| drive wheel, 4 programmable | |||
| driving modes. STOP | |||
| pushbutton | |||
| Smartphone App & | |||
| ECS & Control unitfor | |||
| 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 |
| Android and iOS | |||
| Free features: | |||
| Cockpit, battery capacity, range, | |||
| tour computer via GPS, 4 | |||
| programmable driving modes, | |||
| On/Off rear light, worldwide | |||
| service contact details, firmware | |||
| updates over the air, failure and | |||
| warnings | |||
| chargeable: Navigation | |||
| Control unit Pairing Reset Turn on/off |
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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.