(394 days)
- Any individual who needs a power wheelchair and can not stand up on their own such as people with paraplegia, spina bifida, cerebral paresis, multiple sclerosis, muscular dystrophy and polio
- any individual to take part in sports activities requiring an upright position
The ParaMotion is an all-terrain electric wheelchair with an integrated standing function. All functions are controlled via the joystick control panel. Strong electric motors on the front wheels with wide terrain tires ensure safe handling, and obstacles are overcome easily. The ParaMotion is steered by targeted control of the drive wheels with appropriate operation of the joystick. The dual rear wheel is freely mounted on a steering shaft and thus has a 360° turning radius. This ensures excellent manoeuvrability of the ParaMotion. The joystick control panel also manages the standing function to the driving functions. An electric motor ensures adjustment of the seat from the horizontal position to the upright position. At the same time, the angle of the backrest and the hinges of the leg support are adjusted so that the operator assumes an upright position in the end position. Thanks to the infinitely variable linear motor, any position between the seated position and the standing position can be assumed. All control functions are carried out by means of an R-Net wheelchair control. Thanks to the easy programmability of the R-Net system, the driving functions can be adapted to suit the user's needs.
The ParaMotion device is a stand-up wheelchair. Since this is not an AI/ML device, the typical acceptance criteria related to accuracy metrics are not applicable. Instead, the device's performance is demonstrated through its compliance with various recognized standards for wheelchairs.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Relevant Standards) | Reported Device Performance |
|---|---|
| EN ISO 14971:2012 (Risk Management) | Conforms |
| ISO 7176-1:2014-10 (Static Stability) | Conforms |
| ISO 7176-2:2017-10 (Dynamic Stability) | Conforms |
| ISO 7176-3:2012-12 (Brakes Effectiveness) | Conforms |
| ISO 7176-4:2008-10 (Energy Consumption) | Conforms |
| ISO 7176-5:2008-06 (Dimensions, Mass, Maneuvering Space) | Conforms |
| ISO 7176-6:2018-06 (Max Speed, Acceleration, Deceleration) | Conforms |
| ISO 7176-7:1998-05 (Seating & Wheel Dimensions) | Conforms |
| ISO 7176-8:2014-12 (Static, Impact, Fatigue Strengths) | Conforms |
| ISO 7176-9:2009-11 (Climatic Tests) | Conforms |
| ISO 7176-10:2008-11 (Obstacle-Climbing Ability) | Conforms |
| ISO 7176-11:2012-12 (Test Dummies) | Conforms |
| ISO 7176-13:1989-08-01 (Coefficient of Friction) | Conforms |
| ISO 7176-14:2008-02 (Power & Control Systems) | Conforms |
| ISO 7176-15:1996-11 (Information Disclosure, Documentation, Labeling) | Conforms |
| ISO 7176-16:2012-12 (Resistance to Ignition) | Conforms |
| ISO 7176-21:2009-04 (Electromagnetic Compatibility) | Conforms |
| ISO 7176-22:2014-09 (Set-up Procedures) | Conforms |
| ISO 7176-25:2013-07-15 (Batteries and Chargers) | Conforms |
| ISO 7176-30:2018-12 (Changing Occupant Posture) | Conforms |
| EN 12184:2014 (Non-FDA Recognized Battery Charger Standard) | Conforms |
| DIN EN 61429/A11:2000-01 (Non-FDA Recognized Battery Marking Standard) | Conforms |
| DIN EN 60529:2014-09 (Non-FDA Recognized IP Code Standard) | Conforms |
2. Sample size used for the test set and the data provenance:
The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the subject device." Therefore, there is no mention of a "test set" in the context of clinical or performance data from human subjects. The device's performance is assessed against recognized engineering and safety standards using nonclinical (laboratory and bench) testing. The document does not specify the sample sizes (e.g., number of wheelchairs tested) for each specific nonclinical test conducted to ensure 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:
Not applicable, as no clinical test set using human data was required, and the evaluation was based on compliance with established technical and safety standards.
4. Adjudication method for the test set:
Not applicable, as no clinical test set was used.
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, as this device is a physical medical device (stand-up wheelchair), not an AI/ML diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical medical device.
7. The type of ground truth used:
For this device, the "ground truth" refers to the established requirements and specifications outlined in the FDA-recognized and non-FDA-recognized international and national standards for wheelchairs. Compliance with these standards (e.g., for stability, braking, speed, safety, risk management, and electromagnetic compatibility) serves as the basis for demonstrating the device's safety and effectiveness.
8. The sample size for the training set:
Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 21, 2022
PowerBaseTec GmbH % Juliane Dinter, PhD Consultant (Lead Project Manager) OiP GmbH Struveweg 40 Ludwigsfelde, 14974 Germany
Re: K203761
Trade/Device Name: ParaMotion Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: Class II Product Code: IPL Dated: November 25, 2021 Received: December 3, 2021
Dear Dr. Juliane Dinter:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
Enclosure
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Indications for Use
510(k) Number (if known) K203761
Device Name ParaMotion
Indications for Use (Describe)
- Any individual who needs a power wheelchair and can not stand up on their own such as people with paraplegia, spina
- bifida, cerebral paresis, multiple sclerosis, muscular dystrophy and polio
• any individual to take part in sports activities requiring an upright position
| 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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Image /page/3/Picture/1 description: The image is a logo for PowerBaseTec, featuring a stylized figure with outstretched wings, superimposed over a shield shape. Above the figure, the word "powerBaseTec" is written in a smaller font. Below the figure, the letters "PBT" are prominently displayed in a bold font. The logo has a clean and modern design.
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92.
Contact Information
| Date of preparation | January 2022 |
|---|---|
| Name | PowerBaseTec GmbH |
| Address | Göttinger Landstr. 14a 37434 Gieboldehausen |
| Contact Person | Niclas NachtweyGeneral Manager |
| info@powerbasetec.de | |
| Phone | +49(0) 5528 2000660 |
Application Correspondent (Consultant)
| Name | QiP GmbH |
|---|---|
| Address | Struveweg 4014974 LudwigsfeldeGermany |
| Alternate Contact | Dr. rer. medic. Juliane DinterLead Project Manager |
| j.dinter@qip-qm.com | |
| Phone | +49 3378 2055 180 |
| Fax | +49 3378 2055 182 |
Subject Device
| Trade Name | ParaMotion | ||
|---|---|---|---|
| Common Name | Standup Wheelchair | ||
| Classification Name | Wheelchair, Standup | ||
| Regulatory Number | 21 CFR 890.3900 | ||
| Product Code | IPL | ||
| Device Class | II |
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Image /page/4/Picture/1 description: The image is a logo for PowerBaseTec, which is abbreviated as PBT. The logo is green and white and features a shield with wings. The wings are spread out on either side of the shield. The letters PBT are in large, bold font in the center of the shield.
| Review Panel | Physical Medicine |
|---|---|
| Predicate Device | |
| Trade Name | ParaGolfer |
| Common Name | Standup Wheelchair |
| Classification Name | Wheelchair, Standup |
| Regulatory Number | 890.3900 |
| Product Code | IPL |
| Device Class | II |
| Review Panel | Physical Medicine |
| 510(k) number | K060936 |
| Clearance | August 07, 2006 |
Subject Device Description
The ParaMotion is an all-terrain electric wheelchair with an integrated standing function.
All functions are controlled via the joystick control panel. Strong electric motors on the front wheels with wide terrain tires ensure safe handling, and obstacles are overcome easily. The ParaMotion is steered by targeted control of the drive wheels with appropriate operation of the joystick. The dual rear wheel is freely mounted on a steering shaft and thus has a 360° turning radius. This ensures excellent manoeuvrability of the ParaMotion.
The joystick control panel also manages the standing function to the driving functions. An electric motor ensures adjustment of the seat from the horizontal position to the upright position. At the same time, the angle of the backrest and the hinges of the leg support are adjusted so that the operator assumes an upright position in the end position. Thanks to the infinitely variable linear motor, any position between the seated position and the standing position can be assumed.
All control functions are carried out by means of an R-Net wheelchair control. Thanks to the easy programmability of the R-Net system, the driving functions can be adapted to suit the user's needs.
Indications for Use
- Any individual who needs a power wheelchair and can not stand up on their own such as people with paraplegia, spina bifida, cerebral paresis, multiple sclerosis, muscular dystrophy and polio
- any individual to take part in sports activities requiring an upright position
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Image /page/5/Picture/1 description: The image is a logo for PowerBaseTec, featuring a stylized design with wings and the letters "PBT" prominently displayed. The wings are spread out above the letters, creating a sense of flight or power. The text "powerBaseTec" is written in a smaller font above the wings. The logo uses a green and white color scheme, giving it a clean and professional look.
Intended Use Statement
The sports wheelchair is designed solely for persons who are unable to walk or have a walking impediment for doing indoor or outdoor sports that require an upright body position. The ParaMotion was specially designed for users who are able to independently move in a sports wheelchair.
Comparison with Predicate Device
The ParaMotion is substantially equivalent to the ParaGolfer Otto Bock HealthCare, cleared on August 07, 2006 as K060936.
The ParaMotion is the follow-on device of the ParaGolfer and was designed on the technical basis by the company PowerBaseTec. The ParaMotion has the identically constructed drives, batteries and performance data and is based on the Design of the ParaGolfer. The control technology was replaced by an advanced control technology from Curtis Wright (R-NET). The stand-up unit (seat unit) was developed based on the stand-up unit of the ParaGolfer and optimized in order to improve he usability of the user (for instance an active seat shifting for Decubitus prevention was integrated) and to ensure more efficient repairs by trained technicians. The intended users are identical for both devices (ParaGolfer and ParaMotion). Based on technical, clinical and biological characteristics the ParaMotion is substantially equivalent to the ParaGolfer and may be viewed as follow-up product.
The following table provides a comparison of technological characteristics with the predicate device and the reference device to demonstrate substantial equivalence.
| Characteristic | Subject Device | Predicate DeviceK060936 | Justification forSubstantialEquivalence |
|---|---|---|---|
| Manufacturer | PowerBaseTec GmbH | Otto Bock | Not applicable |
| Model | ParaMotion | ParaGolfer | Not applicable |
| Device Classification | Class II | Identical | |
| Classification Panel | 890.3900, IPL | Identical | |
| Characteristic | Subject Device | Predicate DeviceK060936 | Justification forSubstantialEquivalence |
| Regulation Name | Physical Medicine Devices, Physical MedicineProsthetic Devices Standup Wheelchair | Identical | |
| Indications for Use | • Any individual whoneeds a powerwheelchair and cannot stand up ontheir own such aspeople withparaplegia, spinabifida, cerebralparesis, multiplesclerosis, musculardystrophy and polio• any individual totake part in sportsactivities requiringan upright position | • Any individual whoneeds a powerwheelchair and cannot stand up ontheir own such aspeople withparaplegia, spinabifida, cerebralparesis, multiplesclerosis, musculardystrophy and polio• any individual totake part in sportsactivities requiringan upright position | Identical |
| Intended UseStatement | The sports wheelchairis designed solely forpersons who areunable to walk or havea walking impedimentfor doing indoor oroutdoor sports thatrequire an uprightbody position. TheParaMotion wasspecially designed forusers who are able toindependently movein a sports wheelchair. | The ParaGolferStandup Wheelchairis a front wheel drivepowered standupwheelchair with anair-filled rear wheelfor active users.These wheelchairsprovidemobility to physicallychallenged persons.The wheelchair canbe moved by the useroperating the CurtisInstruments MC-2Control System that isconnected to theMicro Motor. Thewheelchair is steeredby different rotationof the rear wheel. Itfeatures a servo-steering with releasemechanism. TheParaGolfer has anintegrated stand-up | The intended use of thesubject and predicatedevice is similar. |
| function. When | |||
| actuating the standup | |||
| function via the | |||
| control console, a | |||
| motorized | |||
| lifting device moves | |||
| the seat of the | |||
| ParaGolfer from a | |||
| horizontal to vertical | |||
| position. | |||
| At the same time the | |||
| angles on the | |||
| backrest and footrest | |||
| adapt in such a way | |||
| that the | |||
| user is brought to an | |||
| upright posture. | |||
| Characteristic | Subject Device | Predicate DeviceK060936 | Justification forSubstantialEquivalence |
| Patient Population | active handicappedusers or disabledpeople unable to walk | Information notpublicly available | Identical |
| Intended Users | active handicappedusers or peopleunable to walk | Information notpublicly available | Identical |
| Frame material | • Base frame- Steelpowder Coated• Seat frame- Steelpowder Coated andAluminium PowderCoated• Covering- GRPlaminate withgelcoat coating | Information notpublicly available | Similar withdifferences; notclinical relevant due toISO 10993-seriescompliance. |
| Frame Design/ Style | U frame | Information notpublicly available | Identical |
| Folding mechanism | No, backrest andfootrest for transport | Information notpublicly available | Very similar in termsof folding of thebackrest and thefootrest only for thesubject device. Notclinically relevant interms of safety andperformance. |
| Seating design | mechanical seatconstruction withstand-up function | Information notpublicly available | Identical |
| Seating attachment(integrated, powerbase, specialty power) | integrated | Information notpublicly available | Identical |
| Overall Dimensions | - | - | - |
| Length (whendriving forward):Total length(packing size) | When drivingforward:1620mmTotal length:1375mm | Information notpublicly available | Different but noclinical relevant ofcritical differences forthe user and therefore |
| Characteristic | Subject Device | Predicate DeviceK060936 | Justification forSubstantialEquivalence |
| Width | 900 mm | Information notpublicly available | no adverse impact onsafety andeffectiveness of thesubject device.Identical |
| Height | 1010 mm (in sittingposition – dependingon the position of thebackrest) | Information notpublicly available | Different. The subjectdevice has a longertotal height than thepredicate device. Adifferent height is notclinically relevant orhas critical differencesfor the user. Thedifferent has thereforeno adverse impact onsafety andeffectiveness of thesubject device. |
| Seat dimensions | - | - | - |
| Seat width | 295 – 465 mm | Information notpublicly available | Identical |
| Seat depth | 340 – 520 mm | Information notpublicly available | Identical with adifferent range. |
| Seat height | 500 – 645 mm | Information notpublicly available | The subject device hasa smaller seat heightthan the predicatedevice. |
| Weight | 40,2 kg | Information notavailable | No comparisonpossible. Due tosimilar wheelchairweight thisinformation is notclinically relevant. |
| Wheelchair Weight | 212,2 kg | Information notpublicly available | Subject device isheavier than thepredicate device. Notrelevant in terms ofintended purpose. |
| With batteries | 80 kg | Information notpublicly available | Identical |
| Without batteries | 132,2 kg | Information notpublicly available | Subject device isheavier than thepredicate device. Notrelevant in terms ofintended purpose. |
| Controller | 120 Amps | Information not publicly available | The subject device has a smaller controller |
| Characteristic | Subject Device | Predicate Device K060936 | Justification for Substantial Equivalence output than the predicate device. |
| Drive style (e.g. rear, mid, front) | front | Information not publicly available | Identical |
| Motor type | 2 DC Motors pulse width modulation | Information not publicly available | Identical |
| Motor output | 550 W (24V) | Information not publicly available | Identical |
| Batteries | - | - | - |
| Quantity | 2 | Information not publicly available | Identical |
| Type | 2 x gel battery 12 V 93,5 Ah (C5) | Information not publicly available | Identical |
| Chemistry | Lead acid | Information not publicly available | Identical |
| Range per Charge (off-road, golf course***) | approx. 24,9 miles (40 km) | Information not publicly available | Identical |
| Charger Type (On-board/Off-board/Carry-on) | Off- boardSwede classic 10A IP 54 | Information not publicly available | Different, but no negative effect in terms of safety or performance of the subject device. |
| Input/Output Power | AC 115 V 60 Hz (325W)DC 10A (24V) | Information not publicly available | Identical |
| Actuator | Linak LA 30 12/24V DC permanent magnet motor | Information not publicly available | Identical |
| Brake | electromagnetic spring brake | Information not publicly available | Identical |
| Minimum braking distance and time | - | - | - |
| Image: PBT logo | |||
| Forward | At speed of10,0km/h[6.2 mph]1710 mm (on the horizontal)2800 mm (-17° slope)At speed of10,0km/h[6.2 mph]1710 mm (on the horizontal)Time:1,7 m/s | Information notpublicly available | Identical |
| Reverse | v [km/h]4 0,65 0,86 17 1,28 1,59 1,810 2,111 2,512 2,913 3,414 3,915 4,5 | Information notpublicly available | |
| Wheel Lock (type) | Magnetic springloaded brake | Information notpublicly available | Identical |
| Max speed | |||
| Forward | 6.2 mph [10.0 km/h] | Information notpublicly available | Identical |
| Reverse | 2,91 mph [4,68 km/h] | Information notpublicly available | Cannot be evaluated. |
| Rear Wheels Size | 10,82 Inch(11x6.00-5) | Information notpublicly available | Identical |
| Quantity | 2 | Information notpublicly available | Different, botuncritical in terms ofsafety andperformance betweensubject and predicatedevice. |
| Tire pressure (ifpneumatic) | recommended:21,5 PSIminimal:14,5 PSImaximum: 43,51 PSI | Information notpublicly available | Identical |
| Castors size | 15,35 inch(16x7.50-8) | Information not publicly available | Almost identical; no influence on safety and performance of the devices. |
| Quantity | 2 | Information not publicly available | Identical |
| Tire Pressure (if pneumatic) | recommended: 21,5 PSIminimal:14,5 PSImaximum: 24,65 PSI | Information not publicly available | Almost identical; no influence on safety and performance of the devices. |
| Anti-tip Wheels | None | Information not publicly available | Identical |
| Removable (Yes/No) | None | Information not publicly available | Identical |
| Style | none | Information not publicly available | Identical |
| Suspension (if applicable) | Coil Spring | Information not publicly available | Different. |
| Maximum Occupant Mass | 140 kg (308,6 LBS) | Information not publicly available | Identical |
| Curb Climbing ability | no | Information not publicly available | Identical |
| Ground clearance | 3,94 inch (10cm) | Information not publicly available | Identical |
| Minimum Turning Radius | 1900 mm | Information not publicly available | Identical |
| Maximum Incline | 17,2 ° (31%) | Information not publicly available | Identical |
| Footplates | Foldable | Information not publicly available | Different, but no influence on safety and performance of the devices. |
| Back Upholstery | Material identical to seat cushion | Information not publicly available | Identical |
| Armrest Type | Material identical to seat cushion | Information not publicly available | Identical |
| Operating surface & environment | off-road, golf course | Information not publicly available | Identical |
| Additional Accessory | Golf Bag holderKnee padSafety beltSpecial PaintSeat CushionStow BoxInside pads | Information not publicly available | Identical |
| Warranty | 2 years (24 month)Except wearing parts | Information not publicly available | Identical |
| Additional characteristics | |||
| Seat inclination | 0° | Information not publicly available | Identical |
| Armrest height | 155 – 245 mm(steplessly adjustable) | Information notpublicly available | Identical |
| Armrest length | 280 mm | Information notpublicly available | Identical |
| Lower leg length | 430-530mm | Information notpublicly available | The subject device hasa smaller lower leglength than thepredicate device. |
| Backrest height | 340 - 445 mm(steplessly adjustable) | Information notpublicly available | Different, but nocritical differencewhich is not clinicallyrelevant and hastherefor no adverseimpact on safety andeffectiveness of thedevice. |
| Tire size | 390 mm | Information notpublicly available | Identical |
| Characteristic | Subject Device | Predicate DeviceK060936 | Justification forSubstantialEquivalence |
| Tire size (rear tire) | 275 mm | Information notpublicly available | Identical |
| Radius turning circle | 1900 mm | Information notpublicly available | Identical |
| Drive | Electrical | Information notpublicly available | Identical |
| Batteries | Group 24 | Information notpublicly available | Identical |
| Engines | Kolektor | Information notpublicly available | Identical |
| Tires | Knobby-3 | Information notpublicly available | Identical |
| Rollable | Yes | Information notpublicly available | Identical |
| Type of drive | Front-wheel drive | Information notpublicly available | Identical |
| Control system | R-Net /Curtis-Wright | Information notpublicly available | The control system ofthe subject device isdifferent than thecontrol system of thepredicate device. |
| stand-up function | Yes | Information notpublicly available | Identical |
| Charger /Manufacturer | Swede Electonics | Information notpublicly available | The manufacturer ofthe charger of thesubject device isdifferent than thecharger of thepredicate device. |
| Nominal slope | Gradeability (in sitting position*): 17° (30%)Lateral tilt stability (in sitting position*): 17° (30%) | Information notpublicly available | Identical |
| Max. User Weight | 308 lbs (140 kg) | Information notpublicly available | Identical |
| Material | • Base frame- Steel powder Coated• Seat frame- Steel powder Coated andAluminium Powder Coated• Covering- GRP laminate withgelcoat coating• Cushions- Foam-Polyethylene /polypropylene foams RX46065 andAlveobloc NA AB 2600 | Information notpublicly available | The subject device ismanufacturer fromdifferent material thanthe predicate device. |
| Compliance | ISO 71776 seriesEN 12184DIN EN 61429 | Information notpublicly available | Identical |
| Characteristic | Subject DeviceDIN EN 60529IEC 60335-2-29EMC | Predicate DeviceK060936 | Justification forSubstantialEquivalence |
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Image /page/6/Picture/1 description: The image is a logo for PowerBaseTec, featuring a stylized figure with outstretched wings. The figure is white and positioned above the letters "PBT" in bold, white font with a dark green outline. The logo is set against a dark green shield-like background, and the words "powerBaseTec" are written in a smaller font above the figure.
Page 4 of 14
PowerBaseTec GmbH Goettinger Landstr. 14a 37434 Gieboldehausen Germany
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Image /page/7/Picture/1 description: The image is a logo for PowerBaseTec, which is abbreviated as PBT. The logo features a stylized figure with outstretched wings, superimposed over the letters "PBT". The text "powerBaseTec" is written in a small font above the figure. The logo is green and white and is set against a white background.
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Image /page/8/Picture/1 description: The image is a logo for PowerBaseTec. The logo features a stylized figure with outstretched wings, resembling a person with wings. Below the figure are the letters "PBT" in a bold, sans-serif font. The logo is primarily green and white, with the figure and letters in green against a white background.
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Image /page/9/Picture/1 description: The image shows a logo for PowerBaseTec (PBT). The logo features a stylized figure with outstretched wings, resembling a person with wings. The letters "PBT" are prominently displayed in a bold, sans-serif font below the figure. The logo is primarily green and white.
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Image /page/10/Picture/1 description: The image is a logo for PowerBaseTec, featuring a stylized figure with outstretched wings. The figure is white and is superimposed over a green shield-like shape. Below the figure, the letters "PBT" are prominently displayed in a bold, green font. Above the figure, the words "powerBaseTec" are written in a smaller font.
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Image /page/12/Picture/1 description: The image is a logo for PowerBaseTec, featuring a stylized figure with outstretched wings. The figure is positioned above the letters "PBT" in a bold, sans-serif font. The logo is primarily green and white, with the text "powerBaseTec" appearing in a smaller font size above the figure. The logo is contained within a shield-like shape.
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Image /page/13/Picture/1 description: The image is a logo for PowerBaseTec (PBT). The logo features a shield shape with a stylized figure with outstretched wings at the top. Below the figure, the letters "PBT" are prominently displayed in a bold, sans-serif font. The entire logo is in a dark green color, giving it a strong and recognizable appearance.
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Image /page/14/Picture/1 description: The image is a logo for PowerBaseTec, featuring a stylized design in green and white. The logo includes a pair of wings spread out, with the text "powerBaseTec" positioned above the wings. Below the wings, the letters "PBT" are prominently displayed in a bold, blocky font, creating a strong visual anchor for the logo.
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Image /page/15/Picture/1 description: The image is a logo for PowerBaseTec (PBT). The logo features a stylized figure with outstretched wings, resembling a person with wings. Below the figure, the letters "PBT" are prominently displayed in a bold font. The entire logo is green and is set against a white background.
Performance Data
The ParaMotion conforms with the following FDA-recognized standards:
- (Recognition number 5-40) EN ISO 14971:2012 - Medical devices - Application of risk management to medical devices (ISO 14971:2007, corrected version 2007-10-01).
- . (Recognition number 16-195) ISO 7176-1:2014-10 - Wheelchairs - Part 1: Determination of static stability
- . (Recognition number 16-202) ISO 7176-2:2017-10 Third edition 2017-10 Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs
- (Recognition number 16-192) ISO 7176-3:2012-12 - Wheelchairs - Part 3: Determination of effectiveness of brakes
- (Recognition number 16-162) ISO 7176-4:2008-10 Wheelchairs Part 4: Energy consumption . of electric wheelchairs and scooters for determination of theoretical distance range
- . (Recognition number 16-163) ISO 7176-5:2008-06 - Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
- . (Recognition number 16-204) ISO 7176-6:2018-06 - Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- (Recognition number 16-196) ISO 7176-7:1998-05 - Wheelchairs - Part 7: Measurement of seating and wheel dimensions
- . (Recognition number 16-197) ISO 7176-8:2014-12 - Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
- . (Recognition number16-167) ISO 7176-9:2009-11 - Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- . (Recognition number 16-164) ISO 7176-10:2008-11 - Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- (Recognition number 16-190) ISO 7176-11:2012-12 Second edition 2012-12-01 Wheelchairs -Part 11: Test dummies
- . (Recognition number 16-25) ISO 7176-13: First edition 1989-08-01 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
- (Recognition number 16-165) ISO 7176-14:2008-02 - Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
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Image /page/16/Picture/1 description: The image is a logo for PowerBaseTec, featuring a stylized figure with outstretched wings, superimposed over the letters "PBT". The figure and letters are in a dark green color. Above the figure, the word "powerBaseTec" is written in a smaller font, enclosed within a shield-like shape. The overall design is clean and professional, suggesting a company involved in technology or power-related industries.
- . (Recognition number 16-27) ISO 7176-15:1996-11 - Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling)
- . (Recognition number 16-191) ISO 7176-16 Second edition 2012-12-01 Wheelchairs - Part 16: Resistance to ignition of postural support devices
- . (Recognition number 16-166) ISO 7176-21:2009-04 - Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
- (Recognition number 16-198) ISO 7176-22:2014-09 Second edition 2014-09-01 Wheelchairs -Part 22: Set-up procedures
- . (Recognition number 16-194) ISO 7176-25 First edition 2013-07-15 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
- . (Recognition number 16-206) ISO 7176 - 30 First edition 2018-12 Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements
Additionally, the ParaMotion complies with the following non-FDA-recognized standards
- . EN 12184:2014 - Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
- DIN EN 61429/A11:2000-01 - Marking of secondary cells and batteries with the international recycling symbol ISO 7000-1135 and indications regarding directives 93/86/EEC and 91/157/EEC
- DIN EN 60529:2014-09 - Degrees of protection provided by enclosures (IP Code)
Clinical Studies
- Clinical testing was not required to demonstrate the safety and effectiveness of the subject device.
Conclusions
The conclusions drawn from the nonclinical and clinical tests demonstrated that the device is as safe, as effective, and performs as well as or better than the legally marketed device ParaGolfer (K060936). The Paramotion and Predicate device, Paragolfer are substantially equivalent.
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).