Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and electrical components controlled by a standard joystick and a programmable R-Net system, with no mention of AI or ML algorithms for control, analysis, or adaptation beyond basic programmability.

Therapeutic

No
The device is a power wheelchair with a standing function, intended to assist individuals with mobility impairments and for participation in sports activities. While it aids users, it does not directly treat or diagnose a medical condition.

Diagnostic

No

The device is an electric wheelchair with an integrated standing function, designed to assist individuals with mobility impairments. Its function is to provide mobility and support, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as electric motors, wheels, a joystick control panel, and a linear motor for the standing function. While it mentions a control system (R-Net), the device is fundamentally a physical wheelchair with integrated hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Description: The ParaMotion is an electric wheelchair with a standing function. It is a physical device used for mobility and positioning, not for analyzing biological samples.
Intended Use: The intended use is for individuals who need a power wheelchair and cannot stand on their own, and for participating in sports activities requiring an upright position. This relates to physical function and mobility, not diagnostic testing.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples, laboratory procedures, or diagnostic purposes.

Therefore, the ParaMotion is a mobility aid and assistive device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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

Product codes (comma separated list FDA assigned to the subject device)

IPL

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.

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

Active handicapped users or people unable to walk

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)

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
. (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.
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.

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.

K060936

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

Regulation Number and Section

§ 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).

Summary

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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

1

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

2

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 Nachtwey
General Manager
E-Mail	info@powerbasetec.de
Phone	+49(0) 5528 2000660

Application Correspondent (Consultant)

Name	QiP GmbH
Address	Struveweg 40
14974 Ludwigsfelde
Germany
Alternate Contact	Dr. rer. medic. Juliane Dinter
Lead Project Manager
E-Mail	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 Device
K060936 | Justification for
Substantial
Equivalence |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Device
K060936 | Justification for
Substantial
Equivalence |
| Regulation Name | Physical Medicine Devices, Physical Medicine
Prosthetic Devices Standup Wheelchair | | Identical |
| 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 | • 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 | Identical |
| 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. | The ParaGolfer
Standup Wheelchair
is a front wheel drive
powered standup
wheelchair with an
air-filled rear wheel
for active users.
These wheelchairs
provide
mobility to physically
challenged persons.
The wheelchair can
be moved by the user
operating the Curtis
Instruments MC-2
Control System that is
connected to the
Micro Motor. The
wheelchair is steered
by different rotation
of the rear wheel. It
features a servo-
steering with release
mechanism. The
ParaGolfer has an
integrated stand-up | The intended use of the
subject and predicate
device 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 Device
K060936 | Justification for
Substantial
Equivalence |
| Patient Population | active handicapped
users or disabled
people unable to walk | Information not
publicly available | Identical |
| Intended Users | active handicapped
users or people
unable to walk | Information not
publicly available | Identical |
| Frame material | • Base frame- Steel
powder Coated
• Seat frame- Steel
powder Coated and
Aluminium Powder
Coated
• Covering- GRP
laminate with
gelcoat coating | Information not
publicly available | Similar with
differences; not
clinical relevant due to
ISO 10993-series
compliance. |
| Frame Design/ Style | U frame | Information not
publicly available | Identical |
| Folding mechanism | No, backrest and
footrest for transport | Information not
publicly available | Very similar in terms
of folding of the
backrest and the
footrest only for the
subject device. Not
clinically relevant in
terms of safety and
performance. |
| Seating design | mechanical seat
construction with
stand-up function | Information not
publicly available | Identical |
| Seating attachment
(integrated, power
base, specialty power) | integrated | Information not
publicly available | Identical |
| Overall Dimensions | - | - | - |
| Length (when
driving forward):
Total length
(packing size) | When driving
forward:1620mm
Total length:1375mm | Information not
publicly available | Different but no
clinical relevant of
critical differences for
the user and therefore |
| Characteristic | Subject Device | Predicate Device
K060936 | Justification for
Substantial
Equivalence |
| Width | 900 mm | Information not
publicly available | no adverse impact on
safety and
effectiveness of the
subject device.
Identical |
| Height | 1010 mm (in sitting
position – depending
on the position of the
backrest) | Information not
publicly available | Different. The subject
device has a longer
total height than the
predicate device. A
different height is not
clinically relevant or
has critical differences
for the user. The
different has therefore
no adverse impact on
safety and
effectiveness of the
subject device. |
| Seat dimensions | - | - | - |
| Seat width | 295 – 465 mm | Information not
publicly available | Identical |
| Seat depth | 340 – 520 mm | Information not
publicly available | Identical with a
different range. |
| Seat height | 500 – 645 mm | Information not
publicly available | The subject device has
a smaller seat height
than the predicate
device. |
| Weight | 40,2 kg | Information not
available | No comparison
possible. Due to
similar wheelchair
weight this
information is not
clinically relevant. |
| Wheelchair Weight | 212,2 kg | Information not
publicly available | Subject device is
heavier than the
predicate device. Not
relevant in terms of
intended purpose. |
| With batteries | 80 kg | Information not
publicly available | Identical |
| Without batteries | 132,2 kg | Information not
publicly available | Subject device is
heavier than the
predicate device. Not
relevant in terms of
intended 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- board
Swede 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 of
10,0km/h[6.2 mph]
1710 mm (on the horizontal)
2800 mm (-17° slope)

At speed of
10,0km/h[6.2 mph]
1710 mm (on the horizontal)

• Seat frame- Steel powder Coated and
Aluminium Powder Coated

• Covering- GRP laminate with
gelcoat coating

DIN EN 60529
IEC 60335-2-29
EMC | Predicate Device
K060936 | Justification for
Substantial
Equivalence |

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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.

9

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.

10

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.

11

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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.

13

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.

14

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.

15

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.