(27 days)
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.
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). Individual 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.
This document describes the premarket notification (510(k)) for the e-motion M25 DuoDrive, a power assist wheelchair conversion kit. The FDA has determined it is substantially equivalent to legally marketed predicate devices.
The information provided does not outline specific acceptance criteria or a detailed study proving the device meets those criteria in the typical sense of a clinical or analytical performance study for an AI/ML-driven medical device. Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices (e-motion M25 (K192618) and SMOOV O10 (K192016)) by comparing technical specifications, intended use, and addressing potential changes (like the addition of a control unit).
Therefore, I cannot directly provide the requested table of acceptance criteria and reported device performance related to an AI/ML model's output metrics (e.g., sensitivity, specificity, AUC). This device is a mechanical/electronic medical device, not an AI/ML diagnostic or prognostic tool.
However, I can extract the relevant information regarding the device's functional and safety characteristics, which serve as its "performance" and "acceptance criteria" in the context of this 510(k):
Acceptance Criteria and Device Performance (Based on Device Specifications and Safety Considerations)
Since this is a mechanical/electronic device, "acceptance criteria" here refer to its technical specifications and demonstration of safety/effectiveness compared to predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Derived from device specifications & safety info) | Reported Device Performance / Specification |
|---|---|---|
| Functional Performance | Maximum User Weight | 150 kg (Subject device & predicate e-motion M25) |
| System Weight | 15.85 kg (Subject device) | |
| Nominal Power | 2x80W (Subject device & predicate e-motion M25) | |
| Max. Assisted Speed | 6...8.5 km/h (Subject device & predicate e-motion M25) | |
| Nominal Range | 25 km (Subject device & predicate e-motion M25) | |
| Power Wheel Range | up to 25 km (as per ISO 7176-4) | |
| Nominal Gradient | 16% [9°] | |
| Operating Temperature | -25° C to +50° C | |
| Battery Type (Drive Unit) | Lithium-ion 10ICR19/66-2 | |
| Rated Operating Capacity (Drive Unit) | 36.5 V | |
| Rated Capacity (Drive Unit) | Ah (Value not specified beyond unit) | |
| Rated Energy (Drive Unit) | Wh (Value not specified beyond unit) | |
| Control Unit Battery Type | Lithium-ion 18650 | |
| Control Unit Rated Voltage | 3.6 VDC | |
| Control Unit Rated Capacity | 2.6 Ah | |
| Control Unit Rated Energy | 9.36W | |
| Wireless Communication | Wireless Technology (Power Unit) | IEEE 802.15.4 (BLE & Classic) |
| RF Freq Range (Power Unit, ECS, Control Unit) | 2.402 GHz to 2.480 GHz | |
| Max Output Power (Power Unit) | 1.5dBm | |
| Max Output Power (ECS, Control Unit) | 5dBm | |
| Wireless Operating Range | 10m / class 2 | |
| Wireless Coexistence Compliance | ANSI C63.27-2017, separation distance >0.25m (Power Unit, ECS, Control Unit) | |
| EMC Compliance | ISO 7176-21:2009 (Power Unit, ECS, Control Unit) | |
| Safety - Cybersecurity | SweynTooth Vulnerability Mitigation | All wireless communication encrypted. |
| Response to successful attack (Normal drive mode) | No influence on driving behavior; device acts independently. | |
| Response to successful attack (Cruise Mode, Remote Mode) | Motor driving support stops to enter safe state (no auxiliary power); unintended movements impossible. | |
| Safety - General | User Interaction | Via two push-rims; optional remote control (ECS), smartphone app, detachable control unit. |
| Compliance with wheelchair manufacturer limits | User must observe wheelchair manufacturer's limits (gradeability, obstacles, user weight, etc.). |
Regarding the other requested information, which is more applicable to AI/ML software as a medical device (SaMD) performance studies:
This 510(k) pertains to a mechanical/electronic power assist device, not an AI/ML algorithm that requires a test set, ground truth experts, or MRMC studies for its core function. Therefore, the following points are not applicable to this specific submission.
2. Sample sized used for the test set and the data provenance: Not applicable for this type of device. Testing would involve engineering performance tests (e.g., battery life, speed, durability) and safety testing for electrical and mechanical hazards, not a "test set" of data for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this device would be established through engineering specifications, standards compliance, and physical testing, not expert interpretation of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device does not involve "human readers" or AI assistance in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no standalone AI algorithm in the context of device performance outlined here. The device itself is a "human-in-the-loop" system, assisting a human wheelchair user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on engineering specifications, international performance and safety standards (e.g., ISO 7176-4, ISO 7176-21), and physical testing (e.g., speed, range, weight capacity, electrical safety, EMC). The "change information" notes that the changes were made under their "design control process," which would involve verifying that the updated design still meets these established specifications and safety requirements.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a "training set" in the computational sense.
9. How the ground truth for the training set was established: Not applicable.
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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 (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
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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 GmbHVor dem Weißen Stein 1472461 Albstadt, GermanyPhone: +49 7432 2006-0Fax: +49 7432 2006-299Email: info@alber.de |
|---|---|
| Contact Person: | Mr Michael VentPhone: +49 30 318 045 30Email: m.vent@beoberlin.de |
| Device: | Proprietary: e-motion M25 DuoDriveCommon Name: Power Assist Conversion Kit for Manual WheelchairsClassification Name: Powered wheelchairDevice Class: II, 21 CFR 890.3860Classification Panel: Physical MedicineProduct Code: ITI |
| Predicate Device: | 510(k): K192618Proprietary: e-motion M25Common Name: Power Assist Conversion Kit for Manual WheelchairsClassification Name: Powered wheelchairDevice Class: II, 21 CFR 890.3860Classification Panel: Physical MedicineProduct Code: ITI |
| Secondary Predicate Device: | 510(k): K192016Proprietary: SMOOV 010Common Name: add-on drive for wheelchairsClassification Name: Powered wheelchairDevice Class: II, 21 CFR 890.3860Classification Panel: Physical MedicineProduct 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(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) ●
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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 DEVICEe-motion M25DuoDrive | PREDICATE DEVICEe-motion M25(K192618) | SECONDARYPREDICATE DEVICESMOOV O10(K192016) | |
|---|---|---|---|
| Indication For Use | The e-motion M25 is a PowerAssist Wheelchair ConversionKit and suitable for the manualwheelchair users who arelimited in their field of activitiesbecause of their physicalconditions. The device canexpand their field of activitiesby assisting their wheelchairoperating force. | The e-motion M25 is a PowerAssist Wheelchair ConversionKit and suitable for the manualwheelchair users who arelimited in their field of activitiesbecause of their physicalconditions. The device canexpand their field of activitiesby assisting their wheelchairoperating force. | The "SMOOV" add-on drive forwheelchairs is intended toprovide auxiliary power tomanual wheelchairs to reducethe pushing power needed bytheir users. It is designed toprovide support to activewheelchair users who arephysically and mentally able tosafely control a manualwheelchair in typical situations,including inclines, evenmanually. |
| Intended Use | The e-motion M25 is a medicaldevice for active wheelchairusers who are reliant on awheelchair as a result of theirdisability. | The e-motion M25 is a medicaldevice for active wheelchairusers with a user weight of 150kgs and who are reliant on awheelchair as a result of their | The SMOOV is a medicaldevice for active wheelchairusers who are reliant on awheelchair as a result of theirdisability. The SMOOV is an |
| The e-motion M25 replaces thewheels that are attached to amanual wheelchair, convertingit into an electrically drivenwheelchair and thussignificantly increasing thewheelchair user's mobility andflexibility.The e-motion M25 must alwaysbe used, transported, maintainedand serviced strictly accordingto the manufacturer'sinstructions. The e-motion M25must only be attached to andoperated with wheelchairs thatare listed in Alber's mountingdatabase.The selection is made by thespecialist dealer or by Alberitself. | disability.The e-motion M25 replaces thewheels that are attached to amanual wheelchair, convertingit into an electrically drivenwheelchair and thussignificantly increasing thewheelchair user's mobility andflexibility.The e-motion M25 must alwaysbe used, transported, maintainedand serviced strictly accordingto the manufacturer'sinstructions. The e-motion M25must only be attached to andoperated with wheelchairs thatare listed in Alber's mountingdatabase. The selection is madeby the specialist dealer or byAlber itself. | add-on drive for wheelchairsthat is attached to a manualwheelchair, converting it into anelectrically driven wheelchairand thus significantlyincreasing the wheelchair user'smobility and flexibility.The SMOOV must always beused, transported, maintainedand serviced as described in theoperating manual. The SMOOVmust only be attached to andoperated with wheelchairs thatare listed in Alber's mountingdatabase.The selection is made by thespecialist dealer or by Alberitself. | |
| Permissible conditionsof use/locations ofoperationType Environment ofUse | • Observe the permissibleconditions of use of thewheelchair to which the e-motion M25 (DuoDrive) isattached.• In addition to observing theinformation provided aboutthe e-motion M25(DuoDrive), it is alsoimperative to observe theinformation provided by thewheelchair manufacturer(e.g. maximum gradeability,maximum permissible heightof obstacles, maximum userweight, maximum speed,etc.). The lowest valuesalways apply.• Any limits regarding theoperation of your wheelchair(e.g. maximum gradeability,maximum permissible heightof obstacles, maximum userweight etc.) must also beobserved when using theM25.• The e-motion M25(DuoDrive) must only beoperated at temperaturesbetween -25 °C and +50 °C.Therefore, do not expose thesmoov to any heat sources(such as intense sunlight) asthis may cause surfaces toreach high temperatures.• The e-motion M25(DuoDrive) is designed forindoor and outdoor use (e.g.solid pavement), avoid usingthe wheelchair on softground (e.g. loose chipping,sand, mud, snow, ice or deeppuddles). | • Observe the permissibleconditions of use of thewheelchair to which the M25is attached.• In addition to observing theinformation provided aboutthe M25, it is also imperativeto observe the informationprovided by the wheelchairmanufacturer (e.g. maximumgradeability, maximumpermissible height ofobstacles, maximum userweight, maximum speed,etc.). The lowest valuesalways apply.• Any limits regarding theoperation of your wheelchair(e.g. maximum gradeability,maximum permissible heightof obstacles, maximum userweight etc.) must also beobserved when using theM25.• The e-motion M25 mustonly be operated attemperatures between -25 °Cand +50 °C. Therefore, donot expose the smoov to anyheat sources (such as intensesunlight) as this may causesurfaces to reach hightemperatures.• The e-motion M25 isdesigned for indoor andoutdoor use (e.g. solidpavement), avoid using thewheelchair on soft ground(e.g. loose chipping, sand,mud, snow, ice or deeppuddles). | • Observe the permissibleconditions of use of thewheelchair to which thesmoov is attached.• In addition to observing theinformation provided aboutthe smoov, it is alsoimperative to observe theinformation provided by thewheelchair manufacturer(e.g. maximum gradeability,maximum permissible heightof obstacles, maximum userweight, maximum speed,etc.). The lowest valuesalways apply.• Any limits regarding theoperation of your wheelchair(e.g. maximum gradeability,maximum permissible heightof obstacles, maximum userweight etc.) must also beobserved when using theSMOOV.• The SMOOV O10 must onlybe operated at temperaturesbetween -25 °C and +50 °C.Therefore, do not expose thesmoov to any heat sources(such as intense sunlight) asthis may cause surfaces toreach high temperatures.• The SMOOV O10 isdesigned for light outdooruse (e.g. solid pavement),avoid using the wheelchairon soft ground (e.g. loosechipping, 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 |
|---|---|---|---|
| WheelchairCompatibility | 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 WheelchairWheel-Diameters(inch) | 22", 24", 25" | 22", 24", 25" | Compatible with wheel diameter 22" - 26" |
| Device WheelDimensions (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 viaclickwheel |
| Control Units | Pushrims & ECS remote control& smartphone app & Controlunit attached to W/C | Pushrims & ECS remote control& smartphone app | Control unit = Bluetoothclickwheel attached to W/C |
| Adjustment of driveparameters | Acceleration in 2 modes:indoor, outdoor, learner mode | Acceleration in 2 modes:indoor, outdoor, learner mode(formerly also called Trainingmode) | acceleration and speeddepending on the angle of thedrive wheel, 4 programmabledriving modes. STOPpushbutton |
| Smartphone App &ECS & Control unitforend 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 | AppAndroid and iOSFree features:Cockpit, battery capacity, range,tour computer via GPS, 4programmable driving modes,On/Off rear light, worldwideservice contact details, firmwareupdates over the air, failure andwarningschargeable: NavigationControl unit Pairing Reset Turn on/off |
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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.
§ 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).