(295 days)
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 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.
This document describes the 510(k) Summary for the SMOOV O10 add-on drive for wheelchairs (K192016). This is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. Therefore, the information provided focuses on comparative performance and compliance with relevant standards, rather than a standalone clinical study with acceptance criteria and reported device performance in the format typically seen for novel diagnostics or treatments.
Here's an attempt to structure the available information based on your request, acknowledging the limitations of a 510(k) summary in providing all requested details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial for a diagnostic device. Instead, substantial equivalence is demonstrated by comparing the subject device (SMOOV O10) to a predicate device (SmartDrive MX2+ K151199) across various technical specifications and intended uses, and by demonstrating conformity to recognized international standards for safety and performance in powered wheelchairs.
The "acceptance criteria" are implied by compliance with these standards and comparable specifications to the predicate device. The "reported device performance" is largely presented through these specifications and the claim of meeting the standards.
| Feature / Standard Compliance | Acceptance Criterion (Implied by Standard/Predicate) | Reported Device Performance (SMOOV O10) |
|---|---|---|
| Intended Use | Auxiliary power to manual wheelchairs to reduce pushing power for active users physically and mentally able to safely control a manual wheelchair. | Matches predicate, provides auxiliary power to manual wheelchairs to reduce pushing power for active users who are physically and mentally able to safely control a manual wheelchair. |
| User Weight | Up to 150 kg (Predicate) | Up to 140 kg |
| Nominal Power of Engine | 250 W (Predicate) | 250 W |
| Max. Assisted Speed | 6-8.9 km/h (Predicate) | 6 km/h (Standard), 10 km/h (Optional) |
| Nominal Range | 19.8 km (Predicate) | Up to 20 km (as per ISO 7176-4) |
| System Weight | 6 kg (Predicate) | 7.2 kg (Drive unit only) |
| Wireless Communication Encryption | Effective mitigation of SweynTooth vulnerabilities (Implied) | All wireless communication is encrypted. Firmware updates performed on affected devices to address vulnerabilities. |
| Safety in case of successful attack (SweynTooth) | Device enters safe state, no unintended movements. | Motor stops, driving support stops (auxiliary power provision ceases). Unintended movements are impossible. |
| General Safety and Performance | Conforms to recognized standards (e.g., ISO 7176 series for wheelchairs, IEC for batteries, ISO 14971 for risk management, biological evaluation standards). | Declared conformity with all listed standards (refer to full list in document). |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of a clinical performance study with human subjects. The evaluation for this 510(k) relies on:
- Comparison to a predicate device: MaxMobility GmbH SmartDrive (MX2+) (K151199).
- Conformity to recognized international standards: A comprehensive list of ISO and IEC standards related to wheelchairs, batteries, biological evaluation, electromagnetic compatibility, and risk management is provided.
- Engineering bench testing: Implied by conformity to standards, but specific sample sizes for these tests are not detailed in this summary.
Data Provenance: Not applicable in the context of a "test set" from a clinical study. The data is largely derived from the technical specifications, design documents, and test reports supporting compliance with the listed standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as there was no "test set" requiring expert ground truth in the clinical sense. The "ground truth" for the device's acceptable performance is established by its adherence to internationally recognized consensus standards and its substantial equivalence to a legally marketed predicate device, as assessed by the manufacturer and reviewed by the FDA.
4. Adjudication method for the test set
Not applicable, as no external clinical test set requiring expert adjudication is described in this 510(k) summary.
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. The SMOOV O10 is an assistive powered wheelchair attachment, not a diagnostic or AI-assisted image analysis tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The SMOOV O10 is a physical medical device (an add-on drive for wheelchairs) with a human user always "in-the-loop" for control and operation. It is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for demonstrating the safety and effectiveness of the SMOOV O10 for this 510(k) is primarily established through:
- Compliance with recognized international standards: These standards define measurable performance and safety criteria accepted by experts in the field of medical devices and assistive technology.
- Comparison to a legally marketed predicate device: Demonstrating that the subject device's design, materials, intended use, and performance are substantially equivalent to a device already deemed safe and effective.
8. The sample size for the training set
Not applicable. The SMOOV O10 is a physical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
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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
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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
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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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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 GmbHVor dem Weißen Stein 2172461 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: SMOOV O10Common Name: add-on drive for wheelchairsClassification Name: Powered wheelchairDevice Class: II, 21 CFR 890.3860Classification Panel: Physical MedicineProduct 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.
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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 thewheelchair manufacturer. |
| Maximum downhill grade: | Depends on the user and weight of the wheelchair. Also notethe 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
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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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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 DEVICESMOOV O10(K192016) | PREDICATE DEVICESmartdrive MX2(K151199) | |
|---|---|---|
| Indication For Use | The SMOOV O10 add-on drive forwheelchairs is intended to provideauxiliary power to manual wheelchairsto reduce the pushing power needed bytheir users.It is designed to provide support toactive wheelchair users who arephysically and mentally able to safelycontrol a manual wheelchair in typicalsituations, including inclines, evenmanually. | The SmartDrive MX2 WheelchairPower Assist is intended to provideauxiliary power to manual wheelchairsto reduce the pushing power needed bytheir users, including pediatrics. It isintended to be used by users capable ofoperating and maneuvering a poweredand manual wheelchair. |
| Intended Use | The SMOOV O10 is a medical devicefor active wheelchair users with a userweight of 140 kgs and who are relianton a wheelchair as a result of theirdisability. The smoov is an add-ondrive for wheelchairs that is attached toa manual wheelchair, converting it intoan electrically driven wheelchair andthus signific- antly increasing thewheelchair user's mobility andflexibility. | The Max Mobility SmartDriveWheelchair Power Assist device isexclusively intended to provideauxiliary power to manual wheelchairsto reduce the pushing power needed bytheir users, including pediatrics, with auser weight of 30 to 331 lbs (14 - 150kgs). It is intended to be used by userscapable of operating and maneuvering apowered and manual wheelchair, |
| The SMOOV O10 must always beused, transported, maintained andserviced carefully to keep itsperformance, efficiency and safety.The SMOOV O10 must only beattached to and operated withwheelchairs that are listed in Alber'smounting database.The selection is made by the specialistdealer or by Alber itself. | ultimately empowering them throughenhanced mobility. | |
| Permissible conditions ofuse/locations of operationType Environment of Use | Observe the permissible conditionsof use of the wheelchair to whichthe smoov is attached. In addition to observing theinformation provided about thesmoov, it is also imperative toobserve the information providedby the wheelchair manufacturer(e.g. maximum gradeability,maximum permissible height ofobstacles, maximum user weight,maximum speed, etc.). The lowestvalues always apply. Any limits regarding the operationof your wheelchair (e.g. maximumgradeability, maximum permissibleheight of obstacles, maximum userweight etc.) must also be observedwhen using the smoov. The SMOOV O10 must only beoperated at temperatures between -25 °C and +50 °C. Therefore, donot expose the smoov to any heatsources (such as intense sunlight) asthis may cause surfaces to reachhigh temperatures. The SMOOV O10 is designed forlight outdoor use (e.g. solidpavement), avoid using thewheelchair on soft ground (e.g.loose chipping, sand, mud, snow,ice or deep puddles). | Do not operate over significantlyrough terrain, very slick surfaces,extreme slopes, or loose ground. Thismay cause a loss of traction, leadingto injury or damage to yourSmartDrive and void the warranty. The SmartDrive is not designed todrive up or down large curbs/steps.Only perform this maneuver whenabsolutely necessary and always askfor help. Also, be sure to turn offyour SmartDrive wristband. Use extreme caution when operatinga SmartDrive at- tached wheelchairwhen near streets. Considerpowering off the wristband to reducethe chance of accident or injury. When crossing major roads,intersection, railway crossings orhighways as well as when you drivesteep, long slopes you should alwaysconsider having somebodyaccompany you in the interest ofyour safety. With regards to driving up and downslopes, please adhere to theinstructions and specifications givenby the diverse wheelchairmanufacturers. Riding over curbs or obstacles cancause tipping and serious bodilyharm. Turn off your SmartDrivewristband when attempting to ride inthese situations. If you have anydoubt that you can safely cross anycurb or obstacle, ALWAYS ask forhelp. Be aware of your riding skillsand personal limitations. Developnew skills only with the help of acompanion. |
| Market Segment | Active | Active |
| Introduced to the market | spring 2019 | 2012 Smartdrive2015 MX2MX2+ |
| 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) | 610 | 68,9 |
| Nominal Range (km) | 20 | 19,8 |
| Assist Levels | Speed adjustments stepless viaclickwheel | Keeps the speed by knocking on thewristband |
| Control Unit | Bluetooth clickwheel attached to W/C | Bluetooth wristband |
| Adjustment of driveparameters | acceleration and speed depending onthe angle of the drive wheel, 4programmable driving modes. STOPpushbutton | Acceleration and stop by tapping thewristband. |
| Smartphone App for end user | Android and iOSFree features:Cockpit, battery capacity, range, tourcomputer via GPS, 4 programmabledriving modes, On/Off rear light,worldwide service contact details,firmware updates over the air, failureand warningschargeable: Navigation | Android and iOSPrimariliy statistical purpose (countingdaily pushes, distance etc.), firmwareupdates over the air. |
Comparison to the Predicate Device
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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.
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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 RiskManagement 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 forbattery chargers | - |
| IEC 62133:2012 | Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - SafetyRequirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, ForUse In Portable Applications [Including: Corrigendum 1 (2013)] | 19-13 |
| UN 38.3 | Recommendations of the TRANSPORT OF DANGEROUS GOODS, Manual of Test andCriteria, 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 ForDetermination 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 OfElectric 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 PoweredWheelchairs | 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 AndScooters - 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 OfElectrically 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 PoweredWheelchairs, 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 ElectromagneticCompatibility (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.
§ 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).