(406 days)
Not Found
No
The description focuses on electromechanical assistance and basic electronic controls. There is no mention of adaptive learning, pattern recognition, or complex decision-making processes characteristic of AI/ML. The "individual adjustment of driving parameters" appears to be user-configured settings, not an AI/ML driven adaptation.
No
The device is a power assist wheelchair conversion kit designed to improve mobility, not to treat or cure a medical condition.
No
This device is a power assist wheelchair conversion kit designed to aid mobility, not to diagnose a medical condition. While it has a "Diagnostics" function in its remote control, this likely refers to self-diagnosis of the device's operational status, not the diagnosis of a patient's health.
No
The device is a Power Assist Wheelchair Conversion Kit which includes significant hardware components such as wheels with motors, control electronics, batteries, and a charger. While it has an optional software component (Smartphone App), the core medical device functionality is provided by the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist manual wheelchair users with mobility by providing power assistance. This is a physical aid, not a diagnostic test performed on biological samples.
- Device Description: The device is a mechanical and electrical system that attaches to a wheelchair to provide propulsion. It does not involve the analysis of biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The e-motion M25 is clearly described as a medical device that enhances mobility for wheelchair users.
N/A
Intended Use / Indications 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 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 disability. The e-motion M25 replaces 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.
Product codes
ITI
Device Description
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 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) and a Smartphone App is available.
The user interacts with the e-motion M25 via push-rim that triggers 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 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-Funtionality (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 are as follows:
- Drive-Mode
- Settings ●
- Diagnostics ●
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 ●
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)
Non-clinical tests according to the above listed recognized standards were performed to demonstrate safety and efficiency of the subject device. The testing included mechanical, electrical and biological safety as well as performance and other relevant aspects.
Clinical tests were not conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 and Drug Administration (FDA). On the left, there 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 Official Correspondent BEO MedConsulting Berlin GmbH Helmholtzstr. 2-9 Berlin. 10587 Germany
Re: K192618
Trade/Device Name: e-Motion M25 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: July 28, 2020 Received: August 6, 2020
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 probibitions 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 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
1
801); medical device reporting (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 (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,
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K192618
Device Name e-motion M25
Indications for Use (Describe)
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.
| 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
| 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
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 |
| Prepared Date: | 25th October 2020 |
Predicate Device Information:
We claim substantial equivalence for the subject device "e-motion M25" in indications for use, design and function to the primary predicate device twion M24 (K151717) and in wireless technology to the secondary predicate device SMOOV O10 (K192016), both PDs by Alber GmbH.
Indications 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.
Intended Use:
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 disability. The e-motion M25 replaces 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.
Device Description:
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 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) and a Smartphone App is available.
The user interacts with the e-motion M25 via push-rim that triggers the assistive power drive.
4
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 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-Funtionality (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 are as follows:
- Drive-Mode
- Settings ●
- Diagnostics ●
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 |
| Operating temperature: | -25° C to +50° C |
| Storage temperature: | -40° C to +65° C |
| Weight of person: | max. 150 kg |
| Max. permissible overall weight: | 180 kg |
5
| Protection rating: | IPx4 |
|---|---|
| Battery pack | |
| Cell type: | Lithium-ion 10ICR19/66-2 |
| Rated operating capacity: | 36.5 V |
| Rated capacity: | Ah |
| Rated energy: | Wh |
| Charging temperature: | 0° C to +45° C |
| Operating temperature: | -25° C to +50° C |
| Protection rating: | IPX4 |
| ECS | |
| Cell type: | AAA |
| Rated voltage: | 3x1.5 VDC |
| Rated capacity: | 750 ... 1000mAh |
| 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% |
Weight of components
Storage
Storage
Air pressure:
Wheel (including battery): ECS (including battery): Battery charger: Total weight:
Operation 10...80% 5...95% Operation 500...1060 hPa 700...1060 hPa
15.6 kg
7.8 kg
0.25 kg
1.2 kg
Radio Frequency Wireless Technology Power Unit
| Type of wireless technology | EEE 802.15.4 (BLE & Classic) |
|---|---|
| FCC compliance: | CFR47, Part 15 |
| FCC ID: | A8TBM78ABCDEFGH |
| Wireless Coexistence Compliance: | ANSI C63.27-2017, separation distance ≥0.25m |
| EMC Compliance | ISO 7176-21:2009 |
| RF frequency range: | 2.402 GHz to 2.480 GHz |
| RF maximum output power: | 1.5dBm |
| Wireless operating range: | 10m / class 2 |
| Wireless functions: | Speed, Emergency stop, Operating mode (on/standby) |
ECS
Type of wireless technology:
IEEE 802.15.4 (Bluetooth Low Energy)
6
| FCC compliance: | CFR47, Part 15 |
|---|---|
| FCC ID: | ZAT26M1 |
| Wireless Coexistence Compliance: | ANSI C63.27-2017, separation distance ≥0.25m |
| EMC Compliance: | ISO 7176-21:2009 |
| Wireless RF frequency range: | 2.402 GHz to 2.480 GHz |
| Wireless RF maximum output power: | 5dBm |
| Wireless operating range: | 10m / class 2 |
| Wireless functions: | 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 in the:
- Normal drive mode An attack during this mode has no influence on driving behaviour as the e-motion ● M25 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 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
(K192618) | PRIMARY PREDICATE
DEVICE
Twion M24 or T24
(K151717) | SECONDARY
PREDICATE DEVICE
SMOOV 010
(K192016) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication For 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
subject device e-motion is an
additional drive for
wheelchairs that is attached
to a manual wheelchair, by
amplifying the user's push
the device significantly
increases the wheelchair
user's mobility and
flexibility.
The e-motion M25 offers
wireless connectivity. | The twion M24 Wheelchair
Drive System is a Power
Wheelchair Conversion Kit
that adds a power assist to a
manual wheelchair, thereby,
turning a manual wheelchair
into a power-assisted
wheelchair. It is a push-and-
brake assist working in both
directions. The intended use
is to provide mobility to
persons limited to a seated
position that are capable of
operating a powered and
manual wheelchair. | The SMOOV 010 drive unit
is attached and detached to
rigid wheelchairs via a
bracket or alternatively to a
foldable wheelchair with an
optional adapter. The
SMOOV 010 converts the
user s manual wheelchair,
when needed, in a partly
motorized wheelchair to
extend the mobility and
flexibility of the wheelchair
user. To extend functionality
an optional Smartphone App
is available. The smoov add-
on drive offers the same |
| Certain features can be
controlled by a smartphone
app via Bluetooth
connectivity. | The twion doesn't offer
wireless connectivity. | wireless connectivity as the
e-motion M25. Certain
features can be controlled by
a smartphone app via
Bluetooth connectivity. | |
| 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
T24 is attached. In addition to observing
the information provided
about the T24, it is also
imperative to observe the
| 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). | |
| Permissible conditions
of use/locations of
operation
Type Environment of
Use | | | |
| Market Segment
Active | Active | Active | |
Comparison to the Predicate Device
7
8
| Introduced to the
| market | spring 2020 | 2014 | spring 2019 |
|---|---|---|---|
| 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" | 24" | 22" - 26" |
| Device Wheel | |||
| Dimensions (inch) | 22", 24", 25" | 24" | Diameter: 6.4" |
| Width: 3,9" | |||
| Max. user weight (kg) | 150kg | 120kg | 140 |
| System weight (kg) | 15.6kg | 12kg | 7,95kg |
| Nominal Power (Watt) | 2x80W | 2x60W | 250W |
| Max. assisted Speed | |||
| (km/h) | 6...8.5km/h | 6...10km/h | 6 / 10km/h |
| Nominal Range (km) | 25km | 15km | 20km |
| Assist Levels | Push-force support | Push-force support | Speed adjustments stepless |
| via clickwheel | |||
| Control Unit | Pushrim & ECS & | ||
| Smratphone App | Pushrim | Bluetooth clickwheel | |
| attached to W/C | |||
| Adjustment of drive | |||
| parameters | Acceleration in 2 modes: | ||
| indoor, outdoor , Training | |||
| Mode | none | acceleration and speed | |
| depending on the angle of | |||
| the drive wheel, 4 | |||
| programmable driving | |||
| modes. STOP pushbutton | |||
| Smartphone App & | |||
| ECS for end user | App Cockpit (drive-, tour-data) Navigation Drive-Mode (Cruise/Speed) Remote ECS (find below) ECS Pairing Reset Turn on/off Drive-Mode (indoor / outdoor) Training-Mode Roll-Back-Prevention Sleep-Mode | 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 |
9
Predicate devices and the subject device are designed to active wheelchair users who are physically and mentally able to safely control a manual wheelchair in typical situations, including inclines, even manually.
Both SD and PDs are provided as accessory to standard manual wheelchairs in order to provide assistive power for the user. Both devices, PD1 and SD are similar in their technological and performance characretistics The PD2 includs the wireless controller-components. It was also demonstrated that their technological characteristics are equivilant.
The devices are meant for Over-the-counter sale and do not require any set-up or training besides the instructions on the labeling.
Even the wording to describe the indications for use and the intended use slightly differ, the devices are considered substantially equivalent concerning these aspects.
The subject device is in conformity with the technical and performance requirements of the following FDA recognized Standards and Guidance Documents:
| Standard | Name | Recognition# |
|---|---|---|
| ISO 10993-1:2009 | Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk | |
| Management Process | 2-220 | |
| ISO 10993-5:2009 | Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | 2-245 |
| ISO 10993-10:2010 | Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization | 2-174 |
| IEC 60335-2-29:2016 | Safety of household and similar electrical appliances Part 2-29: Particular requirements for | |
| battery chargers | - | |
| IEC 62133:2012 | Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety | |
| Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For | ||
| Use In Portable Applications [Including: Corrigendum 1 (2013)] | 19-13 | |
| UN 38.3 | Recommendations of the TRANSPORT OF DANGEROUS GOODS, Manual of Test and | |
| Criteria, Part III, Lithium metal and lithium ion batteries | - | |
| ISO 7176-1: 2014 | Wheelchairs - Part 1: Determination Of Static Stability | 16-195 |
| ISO 7176-2: 2017 | Wheelchairs - Part 2:Determination Of Dynamic Stability Of Electrically Powered Wheelchairs | 16-202 |
| ISO 7176-3: 2012 | Wheelchairs - Part 3: Determination Of Effectiveness Of Brakes | 16-192 |
| ISO 7176-4: 2008 | Wheelchairs - Part 4: Energy Consumption Of Electric Wheelchairs And Scooters For | |
| Determination Of Theoretical Distance Range | 16-162 | |
| ISO 7176-5: 2008 | Wheelchairs - Part 5: Determination Of Overall Dimensions, Mass And Manoeuvring Space | 16-163 |
| ISO 7176-6: 2018 | Wheelchairs - Part 6: Determination Of Maximum Speed, Acceleration And Deceleration Of | |
| Electric Wheelchairs | 16-204 | |
| ISO 7176-8: 2014 | Wheelchairs - Part 8: Requirements And Test Methods For Static, Impact And Fatigue Strengths | 16-197 |
| ISO 7176-9: 2009 | Wheelchairs - Part 9: Climatic Tests For Electric Wheelchairs | 16-167 |
| ISO 7176-10: 2008 | Wheelchairs - Part 10: Determination Of Obstacle-Climbing Ability Of Electrically Powered | |
| Wheelchairs | 16-164 | |
| ISO 7176-11: 2012 | Wheelchairs - Part 11: Test Dummies | 16-190 |
| ISO 7176-13: 1989 | Wheelchairs - Part 13: Determination Of Coefficient Of Friction Of Test Surfaces | 16-25 |
| ISO 7176-14: 2008 | Wheelchairs - Part 14: Power And Control Systems For Electrically Powered Wheelchairs And | |
| Scooters - Requirements And Test Methods | 16-165 | |
| ISO 7176-15: 1996 | Wheelchairs - Part 15: Requirements For Information Disclosure, Documentation And Labeling | 16-27 |
| ISO 7176-21: 2009 | Wheelchairs - Part 21: Requirements And Test Methods For Electromagnetic Compatibility Of | |
| Electrically Powered Wheelchairs And Scooters, And Battery Chargers | 16-166 | |
| ISO 14971: 2007 | Medical Devices - Application Of Risk Management To Medical Devices | 5-40 |
| ANSI C63.27-2017 | American National Standard For Evaluation Of Wireless Coexistence | 19-29 |
| Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered | ||
| Wheelchairs, and Motorized Three-Wheeled Vehicles | ||
| Guidance for Industry and Food and Drug Administration Staff - Radio Frequency Wireless Technology in Medical Devices | ||
| Guidance for Industry and Food and Drug Administration Staff - Information to Support a Claim of Electromagnetic | ||
| Compatibility (EMC) of Electrically Powered Medical Devices |
We declare the conformity with the recognized standards:
10
Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Non-clinical tests
Non-clinical tests according to the above listed recognized standards were performed to demonstrate safety and efficiency of the subject device. The testing included mechanical, electrical and biological safety as well as performance and other relevant aspects.
Clinical tests
Clinical tests were not conducted.
Quality Assurance and Manufacturing Controls:
Alber GmbH operates to certified quality managementsystem according to EN ISO 13485.
Conclusion:
The conclusions drawn from the nonclinical tests including a benefit-risk assessment demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device.