(295 days)
Not Found
No
The description focuses on providing auxiliary power and user control via a physical interface, with no mention of adaptive learning, pattern recognition, or other AI/ML characteristics.
Yes
The device is intended to reduce the physical effort needed by wheelchair users, thereby providing support and extending mobility. This falls under the definition of a therapeutic device as it aids in managing a condition (disability requiring a wheelchair) and improving functional capabilities.
No
The device is an add-on drive for wheelchairs intended to provide auxiliary power and extend mobility. It is not designed to diagnose any medical conditions.
No
The device description clearly states it is a "drive unit" that is "attached and detached to rigid wheelchairs via a bracket" and includes a "control unit mounted to the wheelchair for wireless interfacing with the drive unit." These are physical hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide auxiliary power to manual wheelchairs to reduce the pushing effort needed by users. This is a mechanical function related to mobility and assistance, not the diagnosis of a disease or condition.
- Device Description: The device is described as an add-on drive unit that converts a manual wheelchair into a partly motorized one. This is a physical modification for mobility enhancement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis, monitoring, or screening of diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. The SMOOV O10 does not fit this description.
N/A
Intended Use / Indications for Use
The SMOOV O10 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.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The SMOOV O10 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 user interacts with the SMOOV 010 via control unit mounted to the wheelchair for wireless interfacing with the drive unit. The control unit is used to switch on and off the power assistance and adjust the speed of the drive unit via the turnwheel.
The main parts of the drive unit are as follows:
- . Rotating drive wheel consisting of a brushless motor with tyre and aluminium fork
- Control Electronic for the motor and wireless interface for communication with control unit ● and optional smartphone App
- Integrated lithium ion battery pack with battery management system
- . On/Off button and remaining capacity and operating mode indicator
- Carrying and release handle
- Magnetic charger socket for the integrated battery (Easy Connect) for connecting the battery ● charger
- USB-C socket to charge the control unit or a smartphone
- Position light
- Locking claw for attaching and detaching the drive unit to the bracket ●
The main parts of the control unit are as follows:
- Wireless interface for communicating with the drive unit
- On/Off button and speed setting knob
- 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 unit 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
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)
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 19, 2020
Alber GmbH Michael Vent Official Correspondent for Alber GmbH Vor dem Weißen Stein 21 Albstadt, 72461 DE
Re: K192016
Trade/Device Name: SMOOV 010 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 14, 2020 Received: February 19, 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 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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather Dean, PhD Acting 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
Enclosure
2
Indications for Use
510(k) Number (if known) K192016
Device Name SMOOV 010
Indications for Use (Describe)
The SMOOV O10 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.
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 shows a logo with the word "alber" in lowercase letters. The background is a solid purple color. The word "alber" is written in a sans-serif font, and the letters are white. The logo is simple and modern.
| Applicant: | Alber GmbH
Vor dem Weißen Stein 21
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: SMOOV O10
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 |
| Prepared Date: | 18th May, 2020 |
Predicate Device Information:
We claim substantial equivalence for the subject device SMOOV O10 in intended use, design and function to the predicate device SmartDrive (MX2+) (K151199) by MaxMobility GmbH.
Indications for Use:
The SMOOV O10 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 SMOOV O10 is a medical device for active wheelchair users with a user weight of 140 kgs and who are reliant on a wheelchair as a result of their disability. The smoov is an add-on drive for wheelchairs that is attached to a manual wheelchair, converting it into an electrically driven wheelchair and thus signific- antly increasing the wheelchair user's mobility and flexibility. The smoov must always be used, transported, maintained and serviced as described in this 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.
Device Description:
The SMOOV O10 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 user interacts with the SMOOV 010 via control unit mounted to the wheelchair for wireless interfacing with the drive unit. The control unit is used to switch on and off the power assistance and adjust the speed of the drive unit via the turnwheel.
4
Image /page/4/Picture/0 description: The image is a square with a purple background. The word "alber" is written in white, sans-serif font in the lower left corner of the square. There is a small, circular registered trademark symbol in the upper right corner of the square.
The main parts of the drive unit are as follows:
- . Rotating drive wheel consisting of a brushless motor with tyre and aluminium fork
- Control Electronic for the motor and wireless interface for communication with control unit ● and optional smartphone App
- Integrated lithium ion battery pack with battery management system
- . On/Off button and remaining capacity and operating mode indicator
- Carrying and release handle
- Magnetic charger socket for the integrated battery (Easy Connect) for connecting the battery ● charger
- USB-C socket to charge the control unit or a smartphone
- Position light
- Locking claw for attaching and detaching the drive unit to the bracket ●
The main parts of the control unit are as follows:
- Wireless interface for communicating with the drive unit
- On/Off button and speed setting knob
- 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 unit 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
Drive Unit
| Range: | up to 20 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): | Double the width of the wheelchair (if using the smoov) |
| Maximum speed: | Standard: 6 km/h Optional: 10 km/h |
250 W
36 VDC
170 kg
IPX4
-25° C to +50° C
-40° C to +65° C
max. 140 kg
Rated power of engine: Operating voltage: Operating temperature: Storage temperature: Weight of person: Max. permissible overall weight: Protection rating:
Battery pack
Cell type: Rated operating capacity: Rated capacity:
Lithium-ion 18650 36 V 6.2 Ah
5
Image /page/5/Picture/0 description: The image shows the word "alber" in white font on a purple background. The word is written in lowercase letters and appears to be a logo. The font is rounded and sans-serif, giving it a modern and clean look. The purple background is a solid color, providing a strong contrast to the white text.
| Rated energy: | 224 Wh |
|---|---|
| Charging temperature: | 0° C to +45° C |
| Operating temperature: | -25° C to +50° C |
| Protection rating: | IPX4 |
| Control unit | |
| Cell type: | Lithium-ion 18650 |
| Rated voltage: | 3.6 VDC |
| Rated capacity: | 2.6 Ah |
| Rated energy: | 9.36 Wh |
| Charging temperature: | 0° C to +45° C |
| Operating temperature: | -25° C to +50° C |
| Charger | |
| Model: | Smoov Charger |
| Mains voltage: | 100...240 VAC, 50...60 Hz |
| Power output: | 48 W |
| Output voltage: | 48 VDC |
| Output current: | 1.0 A |
| Protection rating: | IP X4 |
| Ambient temperature: | Operation 0...40 °C |
| Storage | -40...+65 °C |
| Humidity: | Operation 10...80% |
| Storage | 5...95% |
| Air pressure: | Operation 500 1060 hPa |
Weight of components
Storage
Drive unit (including battery): Control unit (including battery): Battery charger: Total weight:
7.2 kg 0.25 kg 0.5 kg 7.95 kg (may differ depending on version or accessories)
700...1060 hPa
Radio Frequency Wireless Technology Drive 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:
Control Unit
Type of wireless technology: FCC compliance: FCC ID:
EEE 802.15.4 (Bluetooth Low Energy) 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)
IEEE 802.15.4 (Bluetooth Low Energy) CFR47, Part 15 ZAT26M1
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Image /page/6/Picture/0 description: The image is a square with a purple background. The word "alber" is written in white, sans-serif font in the lower center of the square. A small circle with a registered trademark symbol is in the upper right corner of the square.
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
Sweyn Tooth 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. The chipsetmanufacturers have issued patches to avoid external attacks. We have performed firmware updates on affected devices. These patches, made to address the vulnerabilities, don't affect device safety or effectiveness.
In the unlikely event a successful attack, the SMOOV O10 motor stops and the driving support stops in order to enter the safe state of the system (=no more auxiliary power provision). Unintended movements are impossible.
| | SUBJECT DEVICE
SMOOV O10
(K192016) | PREDICATE DEVICE
Smartdrive MX2
(K151199) |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication For Use | The SMOOV O10 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. | The SmartDrive MX2 Wheelchair
Power Assist is intended to provide
auxiliary power to manual wheelchairs
to reduce the pushing power needed by
their users, including pediatrics. It is
intended to be used by users capable of
operating and maneuvering a powered
and manual wheelchair. |
| Intended Use | The SMOOV O10 is a medical device
for active wheelchair users with a user
weight of 140 kgs and who are reliant
on a wheelchair as a result of their
disability. The smoov is an add-on
drive for wheelchairs that is attached to
a manual wheelchair, converting it into
an electrically driven wheelchair and
thus signific- antly increasing the
wheelchair user's mobility and
flexibility. | The Max Mobility SmartDrive
Wheelchair Power Assist device is
exclusively intended to provide
auxiliary power to manual wheelchairs
to reduce the pushing power needed by
their users, including pediatrics, with a
user weight of 30 to 331 lbs (14 - 150
kgs). It is intended to be used by users
capable of operating and maneuvering a
powered and manual wheelchair, |
| | | |
| | The SMOOV O10 must always be
used, transported, maintained and
serviced carefully to keep its
performance, efficiency and safety.
The SMOOV O10 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. | ultimately empowering them through
enhanced mobility. |
| Permissible conditions of
use/locations of operation
Type Environment of Use | 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). | Do not operate over significantly
rough terrain, very slick surfaces,
extreme slopes, or loose ground. This
may cause a loss of traction, leading
to injury or damage to your
SmartDrive and void the warranty. The SmartDrive is not designed to
drive up or down large curbs/steps.
Only perform this maneuver when
absolutely necessary and always ask
for help. Also, be sure to turn off
your SmartDrive wristband. Use extreme caution when operating
a SmartDrive at- tached wheelchair
when near streets. Consider
powering off the wristband to reduce
the chance of accident or injury. When crossing major roads,
intersection, railway crossings or
highways as well as when you drive
steep, long slopes you should always
consider having somebody
accompany you in the interest of
your safety. With regards to driving up and down
slopes, please adhere to the
instructions and specifications given
by the diverse wheelchair
manufacturers. Riding over curbs or obstacles can
cause tipping and serious bodily
harm. Turn off your SmartDrive
wristband when attempting to ride in
these situations. If you have any
doubt that you can safely cross any
curb or obstacle, ALWAYS ask for
help. Be aware of your riding skills
and personal limitations. Develop
new skills only with the help of a
companion. |
| Market Segment | Active | Active |
| Introduced to the market | spring 2019 | 2012 Smartdrive
2015 MX2
MX2+ |
| Wheelchair Compatibility | Rigid W/C frames: Universal brackets on the axle tube Folding frames: adapter axle required | Rigid W/C frames: Universal bracket on the axle tube For folding W/C adapter axle required. This axle is firmly connected to the drive unit. |
| Available Wheelchair Wheel-Diameters (inch) | 22" - 26" | 22" - 26" |
| Device Wheel Dimensions (inch) | Diameter: 6.4"
Width: 3,9" | Diameter: 7.6"
Width: 2.8" |
| Max. user weight (kg) | 140 | 150 |
| System weight (kg) | 7,2 | 6 |
| Nominal Power (Watt) | 250 | 250 |
| Max. assisted Speed (km/h) | 6
10 | 6
8,9 |
| Nominal Range (km) | 20 | 19,8 |
| Assist Levels | Speed adjustments stepless via
clickwheel | Keeps the speed by knocking on the
wristband |
| Control Unit | Bluetooth clickwheel attached to W/C | Bluetooth wristband |
| Adjustment of drive
parameters | acceleration and speed depending on
the angle of the drive wheel, 4
programmable driving modes. STOP
pushbutton | Acceleration and stop by tapping the
wristband. |
| Smartphone App for end user | 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 | Android and iOS
Primariliy statistical purpose (counting
daily pushes, distance etc.), firmware
updates over the air. |
Comparison to the Predicate Device
7
Image /page/7/Picture/1 description: The image shows a purple square with the word "alber" in white, lowercase letters. The letters are stylized with rounded edges. In the upper right corner of the square, there is a small, circular logo that is partially obscured.
8
Image /page/8/Picture/0 description: The image shows the word "alber" in white font against a purple background. The word is written in lowercase letters and appears to be part of a logo or brand name. The purple background is a solid color, providing a strong contrast to the white text.
Both, predicate device SmartDrive MX2 and the subject device SMOOV 010 are 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.
Both devices are provided as accessory to standard manual wheelchairs in order to provide assistive power for the user. Both devices are similar in their technological characteristics including their wireless controllercomponents. It was also demonstrated that their technological characteristics are equivalent.
Both 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, both devices are considered substantially equivalent concerning these aspects.
9
Image /page/9/Picture/0 description: The image features a square logo with a purple background. The word "alber" is written in white, lowercase letters across the center of the square. The font is sans-serif, and the letters are slightly rounded. In the upper right corner of the square, there is a small, circular symbol, possibly a registered trademark symbol.
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 | ||
| Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO 10993-1, "Biological |
We declare the conformitv with the recognized standards:
Quality Assurance and Manufacturing Controls:
Alber GmbH operates to certified quality managementsystem according to EN ISO 13485.
Conclusion:
It was demonstrated that the subject device is as safe, as effective and performs as well as the predicate device.