The Power-Flex by Soul Mobility is intended to provide enhanced mobility to disabled persons who are capable of operating a powered and manual wheelchair, by providing powered mobility to manual wheelchairs.

Device Description

Power-Flex is a power-assist drive that can be attached to a manual wheelchair frame, which enables a manual wheelchair to perform like an electrical wheelchair. The Power-Flex drive system includes two drive wheels, two caster wheels for stability, batteries, a control unit, a power supply and a manual tilt mechanism which also acts as an anti-tip preventative. The Power-Flex connects via the manual chair frame standard axle receivers and the rear manual tilt clamp which attaches to the rear rigidizer bar of the manual wheelchair. The manual wheelchair and frame are not part of the drive system and is provided by the customer. The control unit is the steering device of the system

AI/ML Overview

This document is a 510(k) Premarket Notification for a powered wheelchair add-on device, the "Power-Flex." The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a device already legally marketed (a predicate device), and thus does not require a full Premarket Approval (PMA).

The provided text does not contain acceptance criteria or a study proving that the device meets acceptance criteria in the way typically found for medical imaging AI devices (e.g., performance metrics like sensitivity, specificity, AUC). This document pertains to a physical medical device, a powered wheelchair add-on, and its substantial equivalence to a predicate device based on engineering and safety standards, rather than diagnostic accuracy or algorithmic performance.

Therefore, the requested information cannot be fully extracted or accurately inferred from the provided text for the following reasons:

No "Acceptance Criteria" table in the AI/diagnostic sense: The document focuses on compliance with recognized consensus standards (ANSI RESNA WC-1 and WC-2, ISO 7176) and demonstrating similarities to a predicate device (AMP). The "acceptance criteria" for this type of device are adherence to these engineering and safety standards, rather than diagnostic performance metrics.
No "Study" in the clinical trial sense for AI validation: The "study" here is a comparison of product specifications and compliance with established performance standards for wheelchairs. There isn't a "test set" of patient data or "ground truth" adjudicated by experts in the context of an AI/diagnostic study.
No "human-in-the-loop" or "standalone algorithm" performance: These concepts are irrelevant to a powered wheelchair add-on.

However, I can extract information related to the device's adherence to standards and its comparison to a predicate device, which serves a similar function to "proving it meets acceptance criteria" for this type of device.

Re-interpreting for a physical medical device (Powered Wheelchair Add-on):

In the context of this 510(k) submission for a physical medical device, "acceptance criteria" and "study" refer to the demonstration of compliance with recognized performance standards and safety requirements, and to the comparison of the new device's features and performance against a legally marketed predicate device.

Here's an analysis based on that reinterpretation:

Acceptance Criteria and Device Performance (Reinterpreted for a Physical Device)

The "acceptance criteria" for this device are its compliance with various ANSI RESNA and ISO 7176 standards, and its substantial equivalence to the predicate device in terms of safety and effectiveness. The "reported device performance" is how the Power-Flex compares to the predicate and demonstrates compliance with these standards.

1. Table of "Acceptance Criteria" and "Reported Device Performance"

Since there isn't an explicit "acceptance criteria" table with performance metrics in the AI sense, I will create a table summarizing key comparisons between the proposed device (Power-Flex) and the predicate device (AMP), along with the "Comments" from the submission which serve as the "reported performance" against implicit regulatory expectations.

"Acceptance Criteria" Category (Standard Reference / Feature)	Predicate Device (Method Mobility AMP)	Proposed Device (Soul Mobility Power-Flex)	"Reported Device Performance" / Comment on Equivalence
Indications for Use	Enhanced mobility for disabled persons capable of operating powered/manual wheelchairs.	Identical.	Except for branding, Identical to the predicate.
Device Description (Functionality)	Transforms standard wheelchairs into electric mobility devices. Compact, lightweight, easy install.	Power-assist drive attached to manual wheelchair frame enabling electric wheelchair function.	Both provide powered mobility to a manual wheelchair. Main difference is physical attachment method, which applicable standards indicate does not raise safety/effectiveness questions.
Intended Use Environment	Indoors or outdoors on ADA specified/compliant surfaces.	Identical.	Identical to the predicate.
Targeted Population (Wheelchair Width)	Manual chair seat widths 14"-20".	Manual chair seat widths 12"-20".	Minor difference (12" vs 14" low end) does not raise new safety/effectiveness questions; wider range is acceptable.
Weight Limit	265 lbs.	275 lbs.	Minor difference of 10 lbs (<4% of weight) is negligible. Power-Flex tested to 275 lb per standards. Does not raise new safety/effectiveness questions.
Maximum Speed	4 mph.	4.8 mph.	Power-Flex tested and passed applicable standards with 4.8 mph top speed. Common for Group 3 power wheelchairs (min 4.5 mph). Does not raise new safety/effectiveness questions.
Range of Travel (Single Charge)	Up to 11 miles.	Up to 12 miles.	Minor difference in maximum range does not raise new safety/effectiveness questions.
Operating Voltage	25.7 VDC.	24 VDC.	Minor differences in DC voltages do not raise new safety/effectiveness questions.
Attachment Mechanism	Rolls manual chair onto wheel catches, locks wheels, plugs in power lead.	Removes manual chair drive wheels, connects manual chair frame to base via axle pins, attaches anti-tip clamp.	While different, both provide safe/secure attachment. Power-Flex's 3 tool-free attachment points provide safe/effective means.
Host Wheelchair Requirements (Frame Type)	Rigid or folding frame.	Rigid frame only.	Has no effect on safety or effectiveness; only limits type of wheelchair. Manual states this limitation.
Battery Chemistry	Lithium Iron Phosphate.	Lead-acid (2x 12V).	Different chemistries do not raise new safety/effectiveness questions. Both rechargeable.
Compliance to Standards	ANSI RESNA WC-1, WC-2 (ISO 7176)	ANSI RESNA WC-1, WC-2 (ISO 7176)	Both devices comply with applicable standards.

2. Sample size used for the test set and the data provenance:

This is not applicable in the context of an AI/diagnostic study. For a physical device like this, "testing" would refer to engineering and functional tests against the specified ANSI RESNA/ISO standards. The text implies that such testing was conducted to demonstrate compliance (e.g., "Power-Flex tested to 275lb weight per standards," "Power-Flex was tested and passed applicable standards").
There is no "test set" of patient data.
Data provenance: Not applicable in this context. The testing would be carried out by the manufacturer or accredited labs to the specified engineering standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. "Ground truth" for this device is defined by passing the engineering and safety performance requirements specified by the ANSI RESNA and ISO 7176 standards, not by expert interpretation of subject data. Compliance is assessed through physical testing and technical specification comparison, rather than human expert consensus on a diagnostic outcome.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There is no human adjudication process of a "test set" as would be found in an AI diagnostic study. Device compliance is determined by objective measurements against established engineering standards.

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. This is not an AI diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI diagnostic device. Its function is direct physical assistance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's safety and effectiveness is defined by its adherence to the performance and safety requirements outlined in international and national consensus standards (ANSI RESNA WC-1:2019, WC-2:2019, and ISO 7176 Standards). This includes tests for stability, braking, energy consumption, speed, strength, climatic conditions, obstacle climbing, and electromagnetic compatibility. Engineering test results demonstrating compliance with these standards serve as the "ground truth."

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI model requiring a "training set." The design and manufacturing process would involve engineering iterations and testing against specifications, rather than data-driven training.

9. How the ground truth for the training set was established:

Not applicable. See point 8. The "ground truth" for developing such a device revolves around engineering principles, material science, and adherence to established regulatory and consensus standards for medical devices and wheelchairs, rather than a labeled dataset.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 12, 2024

Soul Mobility % John Ziobro Principal Consultant SpectraMedEx, LLC 3215 Golf Road, #149 Delafield, Wisconsin 53018

Re: K242430

Trade/Device Name: Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: August 15, 2024 Received: August 15, 2024

Dear John Ziobro:

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 (the 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 available 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.

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Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Tushar Bansal -S

for 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

Submission Number (if known)

K242430

Device Name

Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Soul Mobility. The word "SOUL" is in large, bold, sans-serif font on the top line. Below that, in a smaller font, is the word "MOBILITY", with a large space between each letter. The logo is in black and white.

K242430 510(k) Summary

1. Summary Date: August 16, 2024
Applicant Name: Soul Mobility 2. 659 River Bluff Circle Oconomowoc. WI 53066 Website: www.soul-mobility.com Owner/Operator Number: Pending
1. Submission Correspondent: On behalf of Soul Mobility, the following consultant is assigned the responsibility of submission correspondence:

Troy Tesmer CEO & Founding Partner Soul Mobility, Inc Ph: 920-691-6700 email:troy@soul-mobility.com

Authorized Correspondent: On behalf of Soul Mobility, the following consultant is authorized to correspond with 4. the agency in regard to this submission:
John F. Ziobro, Principal Consultant SpectraMedEx, LLC 3215 Golf Drive, #149 Delafield, WI 53018 Ph: 262-719-8922 email: jfz@spectramedex.com
న. Trade Name: Power-Flex
1. Powered Wheelchair Common Name:
1. Model Numbers PFX1214 / PFX1517 / PFX1820)
Description: 8. Power-Flex is a power-assist drive that can be attached to a manual wheelchair frame, which enables a manual wheelchair to perform like an electrical wheelchair. The powerflex drive system includes two drive wheels, two caster wheels for stability, batteries, a control unit, a power supply and a manual tilt mechanism which also acts as an anti-tip preventative. The Power-Flex connects via the manual chair frame standard axle receivers and the rear manual tilt clamp which attaches to the rear rigidizer bar of the manual wheelchair. The manual wheelchair and frame are not part of the drive system and is provided by the customer. The control unit is the steering device of the system
1. Manufacturing Site: Lake Air Products 1380 Co Rd E East Vadnais Heights, MN 55110 Ph: (763) 785-2429 Establishment Registration Number: Pending
N/A. The device is not provided sterile, nor does it need to be sterilized. 10. Sterilization Site:
1. Suggested Classification Regulation, Class, Product Code, Description & Panel:

Regulation #	Class	ProductCode	Description	Review Panel
21 CFR 890.3860	II	ITI	Powered Wheelchair	Physical medicine

Soul Mobility - Power-Flex
Traditional 510(k) Submission

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Image /page/5/Picture/0 description: The image shows the logo for Soul Mobility. The word "SOUL" is written in large, bold, sans-serif letters. Below "SOUL" is the word "MOBILITY" written in smaller, sans-serif letters with more space between each letter. The logo is black and white.

1. Reason for Traditional 510(k): New Submission (No previous submissions)
1. Predicate Device(s): AMP
1. 510(k) Number: K231032

15. Manufacturer:	Method Mobility2562 N Fordham AvenueFresno, CA 93727Ph: (888) 882-6788Website: methodmobility.comOwner/Operator Number: 10088920Trade Name: AMP, AMP+Predicate Classification Regulation, Class, Product Code, Description & Panel
-------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Regulation #	Class	ProductCode	Description	Review Panel
21 CFR 890.3860	II	ITI	Powered Wheelchair	Physical medicine

1. Proposed Indication for Use:
  The Power-Flex by Soul Mobility is intended to provide enhanced mobility to disabled persons who are capable of operating a powered and manual wheelchair, by providing powered mobility to manual wheelchairs.
1. Compliance to Special Controls / Performance Standards The recognized ANSI RESNA consensus standards under ITI which are applicable to the proposed device are as follows:
- 16-207 ANSI RESNA WC-1:2019 Section 1, American National Standard for Wheelchairs Volume 1: ● Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability.
- 16-208 ANSI RESNA WC-2:2019 Section 2, American National Standard for Wheelchairs Volume 2: ● Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs.
- . 16-209 ANSI RESNA WC-1:2019 Section 3, American National Standard for Wheelchairs - Volume 1: Additional Requirements for Wheelchairs (including Scooters) Section 3: Determination of effectiveness of brakes.
- 16-210 ANSI RESNA WC-2:2019 Section 4, American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range.
- 16-211 ANSI RESNA WC-1:2019 Section 5, American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space.
- 16-212 ANSI RESNA WC-2:2019 Section 6. American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed of electrically powered wheelchairs.
- 16-213 ANSI RESNA WC-1:2019 Section 7, American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of measurement of seating and wheel dimensions.
- 16-214 ANSI RESNA WC-1:2019 Section 8, American National Standard for Wheelchairs Volume 1: ● Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, Impact and fatigue strengths.
- . 16-215 ANSI RESNA WC-2:2019 Section 9, American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for Electrically powered wheelchairs.

Soul Mobility - Power-Flex Traditional 510(k) Submission

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Image /page/6/Picture/0 description: The image shows the logo for Soul Mobility. The word "SOUL" is written in large, bold, sans-serif letters. Below the word "SOUL" is the word "MOBILITY" written in smaller, sans-serif letters. The logo is black and white.

16-216 ANSI RESNA WC-2:2019 Section 10, American National Standard for Wheelchairs Volume 2: . Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs.
. 16-217 ANSI RESNA WC-1:2019 Section 11, American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test mannequins.
. 16-218 ANSI RESNA WC-1:2019 Section 13, American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of Coefficient of Friction of Test Surfaces.
. 16-219 ANSI RESNA WC-2:2019 Section 14, American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14. Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods.
16-220 ANSI RESNA WC-1:2019 Section 15. American National Standard for Wheelchairs Volume 1: ● Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for Information Disclosure, Documentation and Labeling.
16-223 ANSI RESNA WC-1:2019 Section 22, American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up Procedures.
. 16-224 ANSI RESNA WC-2:2019 Section 21, American National Standard for Wheelchairs - Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters.
16-225 ANSI RESNA WC-1:2019 Section 26, American National Standard for Wheelchairs Volume 1: ● Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary Note: This standard pertains to vocabulary and as such, is not "applied.
. 16-230 ANSI RESNA WC-2:2019 Section 25 , American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries and Chargers for Powered Wheelchairs.
. 16-234 ISO 7176-14 Third Edition 2022, Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
16-235 ISO 7176-25 Second Edition 2022, Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods

Other applied standards are as follows

· ISTA 3A Packaged products for parcel delivery system shipment 70kg (1501b) or Less

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ldentical to the predicate

Room Temperature

ANSI/RESNA WC-1 / WC-2 (ISO 7176 per FDA website listing)

Storage Environment

Standards

Room Temperature

ANSI/RESNA WC-1 / WC-2 (ISO 7176 per FDA website listing)

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Image /page/8/Picture/0 description: The image shows the logo for Soul Mobility. The word "SOUL" is written in large, bold, sans-serif letters. Below "SOUL" is the word "MOBILITY" written in smaller, sans-serif letters. There is a horizontal line below the word "MOBILITY".

Soul Mobility Power-Flex System TRADITIONAL 510(k) SUMMARY

Soul Mobility - Power-Flex Traditional 510(k) Submission

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Image /page/9/Picture/0 description: The image is a logo for Soul Mobility. The word "SOUL" is written in large, bold, black letters on the top line. Below it, the word "MOBILITY" is written in smaller, thinner, black letters. The logo is framed by a thin black border.

1. Differences between the Proposed Device and the Predicate Device:
  The main differences between the Soul Mobility Power-Flex System and the predicate device MP System cleared under K23 002 are as follows:
. Both devices provide powered mobility to a manual wheelchan. The man difference is how they physically attach to the wheelchair. The proposed device requires the removal of the wheelchair while the predicate does not. Both devices utilize centrally located drive wheels and maintain usage of the host manual wheelchair's front casters.
The proposed device can be used only with a rigid frame manual wheelchar, while cither a rigid or folding frame manual ● wheelchair.
Both devices comply with the applicable standards which indicate that these differences do not raise of safety or effectiveness. ●

The Minor differences between the Soul Mobility Power-Flex System and the Mobility AMP System cleared under K23 002 are as follows:

The proposed device ranges from 12-20" while the predicate ranges from 14-20." ●
The proposed device uses a rechargeable lead acid battery while the precisate lithium iron phosphate battery and have DC voltages ● and different access ports for the recharger itself.
The proposed device and the predicate device have different anti-tip mechanisms. ●
The proposed device has a maximum weight limit of 275lbs while the predicate device has a maximum weight limit of 265bs. ●
The proposed device has a maximum speed of 4.8 mph while the predicate device has a maximum speed of 4.0 mph.
The proposed device has a maximum range of 12 miles while the predicate device has a maximum range of 11 miles. ●

The minor differences are a result of customer and both devices comply with the applicable stard these differences do not raise any questions of safety or effectiveness

19. Comparison Summary / Conclusions

Soul Mobility believes the proposed device und the predicate device cleared under K.23 1032 are substantialy equivalent in their intended use, intended users. intended use environment and increase, both devices have the same equivalent technological characteristics. physical characteristics and safety standards. The differences that exise to their features do not affect the relative safety and or effectiveness.

Regulation Number and Section

§ 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).

	Proposed Device	Predicate Device	Comments
Design Variants / FamilyMembers	Soul Mobility - Power-Flex PFX1214 / PFX1517 / PFX1820	Method Mobility AMP (14"-16") / AMP (16"-18") / AMP (18"-20")Cleared under K231032	For visual comparison only
Indications for Use
Device Description	Power-Flex is a power-assist drive that can be attached to a manual wheelchair frame,which enables a manual wheelchair to perform like an electrical wheelchair. ThePower-Flex drive system includes two drive wheels, two caster wheels for stability,batteries, a control unit, a power supply and a manual tilt mechanism which also actsas an anti-tip preventative. The Power-Flex connects via the manual chair framestandard axle receivers and the rear manual tilt clamp which attaches to the rearrigidizer bar of the manual wheelchair. The manual wheelchair and frame are not partof the drive system and is provided by the customer. The control unit is the steeringdevice of the system	The AMP is a groundbreaking power add-on that transforms standard wheelchairs intoelectric mobility devices. Developed with user feedback in mind, the AMP offers anintuitive, user-friendly solution that enhances independence and mobility for peoplewith disabilities.The AMP is designed to be easily installed on most manual wheelchairs, allowing usersto convert their existing chair into a powerful electric mobility device. With itscompact design and lightweight construction, the AMP can be easily transported andattached to a wheelchair in a matter of seconds	Both devices provide powered mobility to a manual wheelchair. The main difference is howthe physically attach to the wheelchair. The proposed device requires the removal of the reawheels of the wheelchair while the predicate does not. Both comply with the applicablestandards which indicate that this difference does not raise any questions of safety oreffectiveness
Indication for Use / IntendedUse	The Power-Flex by Soul Mobility is intended to provide enhanced mobility to disabledpersons who are capable of operating a powered and manual wheelchair, by providingpowered mobility to manual wheelchairs.	The AMP by Method Mobility is intended to provide enhanced mobility to disabledpersons who are capable of operating a powered and manual wheelchair, by providingpowered mobility to manual wheelchairs.	Except for branding, Identical to the predicate
Intended Use Environment	Suitable for: Use indoors or outdoors on ADA specified/compliant surfaces	Suitable for: Use indoors or outdoors on ADA specified/compliant surfaces	Identical to the predicate
Targeted Population	Adolescent children and adults utilizing a manual wheelchair with seat widths ranging from 12" to20" in width and having the capability to utilize and maneuver a power chair both physically andcognitively as assessed by a qualified clinician.	Given their 3 models able to accommodate manual chair seat widths from 14" to 20"it is assumed their target population is the same: Children and adults utilizing amanual wheelchair ranging from 14" to 20" and having the capability to utilize andmaneuver a power chair both physically and cognitively as assessed by a qualifiedclinician.	Both devices provide three variants to accommodate different sizes of manual wheelchairs.The proposed device ranges from 12-20" while the predicate ranges from 14-20." Thetargeted patient population is assumed to be identical. Offering a slightly wider range inwheelchair sizes does not raise any new questions of safety or effectiveness.
Intended User	Disabled persons who are capable of operating a powered and manual wheelchair	Disabled persons who are capable of operating a powered and manual wheelchair	Identical to the predicate
General Similarities
Overview	The Power-Flex is a power base device intended to be attached to an existing manualwheelchair	The AMP is a power base device intended to be attached to an existing manualwheelchair	Identical to the predicate
Major Components	Major Components of the Power-Flex are wheels, frame, motors, motor controller,joystick, rechargeable batteries, anti-tip mechanism	Major Components of the AMP are wheels, frame, motor controller, joystick,rechargeable batteries, anti-tip mechanism	Identical to the predicate
Component Materials	Standard components produced with commonly available mfg materials andprocesses, i.e. - Plastics, Aluminum, Stainless Steel, Powder Coating, Anodizedsurfaces, rubber tires	Standard components produced with commonly available mfg materials andprocesses, i.e. - Plastics, Aluminum, Stainless Steel, Powder Coating, Anodizedsurfaces, rubber tires	Identical to the predicate
Free Wheel / MotorDisengagement	Free Wheel Mode which disables the drive motors allow the device to be attendantpropelled when attached to a manual wheelchair frame	Free Wheel Mode which disables the drive motors allow the device to be attendantpropelled when attached to a manual wheelchair frame	Identical to the predicate
Modularity	The Power-Flex may be removed and the host wheelchair restored to its manualwheelchair configuration	The AMP may be removed and the host wheelchair restored to its manual wheelchairconfiguration	Identical to the predicate
Operator	Power wheelchair operation is carried out by the user and not by an attendant	Power wheelchair operation is carried out by the user and not by an attendant	Identical to the predicate
Operation	Power wheelchair operation is controlled by a joystick input	Power wheelchair operation is controlled by a joystick input	Identical to the predicate
Features / Specifications
Weight Limit	Weight Limit is 275 lbs	Weight Limit is 265lbs	Minor difference of 10lbs( <4% of weight) is netlabel. Power-Flex tested to 275lb weight perstandards. As such, having different weight limits does not raise any new questions of safety oreffectiveness.
Maximum Speed	Maximum Speed is 4.8mph	Maximum speed is 4mph	Speeds in excess of 4.5mph are common amongst power wheelchair applications. Group 3power wheelchairs have a minimum top end speed of 4.5mph. The Power-Flex was tested andpassed applicable standards with the 4.8mph top speed. As such, having different top speedsdoes not raise any new questions of safety or effectiveness.
Range of Travel on singlecharge	Range of the unit is up to 12 miles on a single charge	Range of the unit is up to 11 miles on a single charge	Minor difference is maximum range does not raise any new questions of safety or effectiveness
Operating Voltage	Operating Voltage is 24VDC	Operating Voltage is 25.7VDC	Minor differences in DC voltages does not raise any new questions of safety or effectiveness
Horn	Hand-Operated Horn via push button on joystick controller	Hand-Operated Horn via push button on joystick controller	Identical to the predicate
Battery Level Indication	Battery Level Indicator via LED lights on joystick controller	Battery Level Indicator via LED lights on joystick controller	Identical to the predicate
Speed Level Indication	Speed Level Setting indicator via LED lights on the joystick controller	Speed Level Setting indicator via LED lights on the joystick controller	Identical to the predicate
Power On/Off	On/Off Switch via push button on joystick controller	On/Off Switch via push button on joystick controller	Identical to the predicate
Operating Environment	Indoor and outdoor environment. Avoid extreme cold and/or wet conditions. Donot drive into water or submerge the power base, parts are not water tight	Indoor and outdoor environment. Avoid extreme cold and/or wet conditions. Donot drive into water or submerge the power base, parts are not water tight	Identical to the predicate
	Operating Principles / Technology
Motor Drives	Basic electro-mechanical drive technology consisting of two drive motors and basic gear reduction		Basic electro-mechanical drive technology consisting of two drive motors and basic gear reduction	Identical to the predicate
Braking	Braking is controlled via the microprocessor and based on the user input at the joystick		Braking is controlled via the microprocessor and based on the user input at the joystick	Identical to the predicate
Park Brake	The park brake is electro-mechanical and is removed electronically when the joystick is actuated to move the chair. The default is Park Brake ON when there is no power or input signal to move the chair		The park brake is electro-mechanical and is removed electronically when the joystick is actuated to move the chair. The default is Park Brake ON when there is no power or input signal to move the chair	Identical to the predicate
Free Wheel Mode (Park Brake Off)	Free Wheel Mode - Moving the chair without power or removing the parking brake is done via levers on top of the motor which are rotated to release the mechanical brake		Free Wheel Mode - Moving the chair without power or removing the parking brake is done via levers at the back of the motor which are pushed down to release the mechanical brake	Identical to the predicate
Wheel Configuration	4 wheels: 2 (10") drive wheels located substantially under the manual frame when installed and 2 (5") rear caster wheels for base stability		4 wheels: 2 (8") drive wheels located substantially under the manual frame when installed and 2 (4") casters - 1 each located fore and aft of the drive wheels in the center for base stability	Both devices utilize centrally located drive wheels and maintain usage of the host manual wheelchair's front casters. Therefore, they are substantially equivalent in this respect
Mechanism to attach/detach to wheelchair	The Power-Flex is attached by removing the quick release large drive wheels of the manual chair and then connecting the manual chair frame to the base via right and left axle pins that insert into the manual frame axle receivers. An anti-tip clamp is then attached to the rear of the frame. There are (3) connection points that require no tools. To detach - you reverse the steps and disconnect the rear anti-tip, retract the axle pins and then remove the frame and replace the manual chair drive wheels.		The AMP attaches to the power base by rolling the manual chair backwards onto Wheel Catches that cradle the manual chair drive wheels, locking the manual chair wheels via wheel locks on the manual chair, and then plugging the manual chair into the power base with a power lead mounted on the manual chair during initial set-up. To detach you pull the wheel catch release handle in the rear of the unit, disconnect the power lead, release the manual chair wheel locks, and roll forward out of the wheel catches.	While the systems of attachment are different, both provide a safe and secure means of attaching a manual wheelchair to a power base for enhanced mobility. The 3 attachment points of the Power-Flex utilizing axle pins in the manual chair axle receivers and a secure anti-tip clamp mechanism provides a safe and effective means for attachment.
Host Wheelchair Requirements - Type	Used only with a Rigid frame manual wheelchair. Cannot be used with a folding frame manual wheelchair		Adapts to both rigid and folding frame manual wheelchairs as long as there is 8.5" of ground clearance under the frame to avoid interference with the base.	This has no effect on safety or effectiveness. It only limits the type of wheelchair with which the Power-Flex can be used. The Power-Flex manual clearly states that it cannot be used with a folding frame manual wheelchair. Both comply with the applicable standards which indicate that this difference does not raise any questions of safety or effectiveness.
Host Wheelchair Requirements - Seat Height (Front to Rear)	The Power-Flex has no special requirements for fitment to the power base and maintains the manual chair configuration		The manual chair must have a minimum of 1/2" front to rear seat difference because the base lifts the chair when docked changing the user position	This difference has no effect on safety or effectiveness of the Power-flex as the power base does not require specific front to rear seat differences of the manual frame for the safe configuration when installed.
Software	Software is not controlled or owned by Soul Mobility and is part of the joystick/power module package purchased from the vendor utilized on numerous industry power chair applications		Software is not controlled or owned by AMP Mobility and is part of the joystick/power module package purchased from the vendor utilized on numerous industry power chair applications	Identical to the predicate
Motor Control	Motors are controlled using a microprocessor based motor controller		Motors are controlled using a microprocessor based motor controller	Identical to the predicate
Speed Control	Preselected max-speed, microprocessor controlled speed, acceleration, and deceleration. The user controls these parameters with the joystick		Preselected max-speed, microprocessor controlled speed, acceleration, and deceleration. The user controls these parameters with the joystick	Identical to the predicate
User interface	The user interface is a Joystick and push buttons		The user interface is a Joystick and push buttons	Identical to the predicate
Power	The power source is a rechargeable battery		The power source is a rechargeable battery	Identical to the predicate
Directional Control	Joystick control is used to engage motion in the forward or rearward direction and to steer the chair		Joystick control is used to engage motion in the forward or rearward direction and to steer the chair	Identical to the predicate
Charging	Charging is completed via the provided off-board battery charger and the system is charged via a 3 pin XLR type plug connection under the base of the joystick which is connected to the power base.		Charging is completed via the provided off-board battery charger and the system is charged via a 3 pin XLR type plug connection under the base of the joystick which is connected to the manual wheelchair when the manual chair is connected to the power base electrically. The power base can also be charged independently via a connection under the battery cover if the manual chair is not connected.	Both devices use rechargeable batteries. Offering different recharging methods does not raise any new questions of safety or effectiveness.
Battery	(2) 12V lead-acid wired in series for a 24VDC system - Rechargeable The battery is stored under a cover and can be removed by disconnecting the battery		25.7 VDC Lithium Iron Phosphate System - Rechargeable The battery is stored under a cover and can be removed by disconnecting the primary	Both devices use rechargeable batteries. Offering different battery chemistries does not raise any new questions of safety or effectiveness. Both devices use rechargeable batteries, offering different methods to access/recharge the
Battery Mount	cables from the (4) battery terminals and lifting them out		battery connection to the battery and lifting it out	batteries does not raise any new questions of safety or effectiveness.
Battery Charging	The batteries are charged via a 3 pin connector plugged into the bottom of the joystick connected to the Power-Flex base.		The batteries can be charged via (2) methods. The first is via a 3 pin connector plugged into the bottom of the joystick connected to the manual chair when docked onto AMP base. The second is directly via a connector at the battery when the manual chair is not docked.	The first method of the AMP is substantially equivalent to how the Power-Flex unit charges the batteries and the addition of a second method for when the manual chair is not docked to the AMP has no effect on safety or effectiveness as the Power-Flex does not require the manual chair to be docked to the base for charging as the joystick is mounted to the power base and not the Manual chair like the AMP. Offering different charging methods does not raise any new questions of safety or effectiveness.
Anti-Tip Mechanism	The Power-Flex utilizes a rear clamping mechanism which attaches to the back of the manual frame to provide both a manual tilt and an anti-tip mechanism to the manual frame when installed		The AMP relies on the user to lock his manual chair drive wheels to help prevent tipping and provides an anti-tip bar behind the unit, however, this bar only works if the manual chair is equipped with its own anti-tip bars.	Both devices offer anti-tipping mechanisms and have passed the applicable tests, as such, having a different method does not raise any new questions of safety or effectiveness
Manual Wheelchair width compatibility	Power-Flex is compatible with manual chair seat widths ranging from 12" to 20"		AMP is compatible with manual chair seat widths ranging from 14" to 20"	Both units are adjustable and can adapt to a range of seat widths. The minor difference of 12" vs 14" on the low end has no effect on the safety or effectiveness of the Power-Flex base. The Power-Flex is simply able to adapt to a larger cross section of manual chair seat widths does not raise any new questions of safety or effectiveness.
Manual Wheelchair wheel size compatibility	Power-Flex is compatible with Manual Wheelchair wheel size ranging from 22" to 26' in diameter Power-Flex has a weight of the unit with batteries and no manual frame attached of		Power-Flex is compatible with Manual Wheelchair wheel size ranging from 24" to 26" in diameter The AMP has a weight of the unit with batteries and no manual frame attached of	Both units are adjustable and can adapt to a range of manual chair wheel diameters. The minor difference of 22" vs 24" on the low end has no effect on the safety or effectiveness of the Power-Flex base. The Power-Flex is simply able to adapt to a larger cross section of manual chair wheel diameters does not raise any new questions of safety or effectiveness. The Power-Flex is heavier due to the battery type utilized, larger wheels, and motor sizes.
Power Base Weight	118lbs		42lbs	However, it has no negative effect on the safety or effectiveness of the Power-Flex.