(89 days)
Not Found
No
The description focuses on mechanical and electrical components for power assistance and control, with no mention of AI/ML terms or functionalities like image processing, data analysis for decision making, or learning algorithms.
No.
The device provides enhanced mobility to disabled persons using a manual wheelchair and does not directly treat or prevent a disease or condition.
No
The device is described as a power-assist drive for manual wheelchairs, enhancing mobility for disabled persons. Its function is to provide powered movement, not to diagnose medical conditions or analyze bodily functions.
No
The device description clearly outlines multiple hardware components including drive wheels, caster wheels, batteries, a control unit, a power supply, and a manual tilt mechanism. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Power-Flex by Soul Mobility is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide enhanced mobility to disabled persons by providing powered mobility to manual wheelchairs. This is a mechanical function related to mobility, not a diagnostic test performed on biological samples.
- Device Description: The device description details a power-assist drive system with wheels, batteries, a control unit, etc. These are components of a mobility aid, not equipment used for in vitro diagnostic testing.
- No mention of biological samples or testing: The document does not mention anything about analyzing biological samples (like blood, urine, tissue, etc.) or performing any kind of diagnostic test.
- Anatomical Site: The anatomical site is "Not Applicable," which is consistent with a device that interacts with the user externally for mobility purposes, not internally for diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Power-Flex does not fit this description.
N/A
Intended Use / Indications 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.
Product codes
ITI
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 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.
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
Adolescent children and adults utilizing a manual wheelchair with seat widths ranging from 12" to 20" in width and having the capability to utilize and maneuver a power chair both physically and cognitively as assessed by a qualified clinician.
Intended User / Care Setting
Disabled persons who are capable of operating a powered and manual wheelchair
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
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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
2
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
3
Indications for Use
Submission Number (if known)
K242430
Device Name
Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)
Indications for Use (Describe)
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.
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
-
- 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
-
- 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
-
- Powered Wheelchair Common Name:
-
- 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
-
- 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:
-
- Suggested Classification Regulation, Class, Product Code, Description & Panel:
| Regulation # | Class | Product
Code | 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.
-
- Reason for Traditional 510(k): New Submission (No previous submissions)
-
- Predicate Device(s): AMP
-
- 510(k) Number: K231032
| 15. Manufacturer: | Method Mobility
2562 N Fordham Avenue
Fresno, CA 93727
Ph: (888) 882-6788
Website: methodmobility.com
Owner/Operator Number: 10088920
Trade Name: AMP, AMP+
Predicate Classification Regulation, Class, Product Code, Description & Panel |
| ------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Regulation # | Class | Product
Code | Description | Review Panel |
|-----------------|-------|-----------------|--------------------|-------------------|
| 21 CFR 890.3860 | II | ITI | Powered Wheelchair | Physical medicine |
-
- 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.
- Proposed Indication for Use:
-
- 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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Image /page/7/Picture/0 description: The image contains the logo for Soul Mobility. The word "SOUL" is written in large, bold, sans-serif letters. Below "SOUL" is the word "MOBILITY" written in a smaller, sans-serif font. The logo is black and white.
ldentical to the predicate
ldentical to the predicate
| Proposed Device | Predicate Device | Comments | ||
|---|---|---|---|---|
| Design Variants / Family | ||||
| Members | 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. 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 | The AMP is a groundbreaking power add-on that transforms standard wheelchairs into | |||
| electric mobility devices. Developed with user feedback in mind, the AMP offers an | ||||
| intuitive, user-friendly solution that enhances independence and mobility for people | ||||
| with disabilities. | ||||
| The AMP is designed to be easily installed on most manual wheelchairs, allowing users | ||||
| to convert their existing chair into a powerful electric mobility device. With its | ||||
| compact design and lightweight construction, the AMP can be easily transported and | ||||
| attached to a wheelchair in a matter of seconds | Both devices provide powered mobility to a manual wheelchair. The main difference is how | |||
| the physically attach to the wheelchair. The proposed device requires the removal of the rea | ||||
| wheels of the wheelchair while the predicate does not. Both comply with the applicable | ||||
| standards which indicate that this difference does not raise any questions of safety or | ||||
| effectiveness | ||||
| Indication for Use / Intended | ||||
| 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. | The AMP by Method 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. | 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" to | |||
| 20" in width and having the capability to utilize and maneuver a power chair both physically and | ||||
| cognitively 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 a | ||||
| manual wheelchair ranging from 14" to 20" and having the capability to utilize and | ||||
| maneuver a power chair both physically and cognitively as assessed by a qualified | ||||
| clinician. | 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." The | ||||
| targeted patient population is assumed to be identical. Offering a slightly wider range in | ||||
| wheelchair 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 manual | |||
| wheelchair | The AMP is a power base device intended to be attached to an existing manual | |||
| wheelchair | 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 and | |||
| processes, i.e. - Plastics, Aluminum, Stainless Steel, Powder Coating, Anodized | ||||
| surfaces, rubber tires | Standard components produced with commonly available mfg materials and | |||
| processes, i.e. - Plastics, Aluminum, Stainless Steel, Powder Coating, Anodized | ||||
| surfaces, rubber tires | Identical to the predicate | |||
| Free Wheel / Motor | ||||
| Disengagement | Free Wheel Mode which disables the drive motors allow the device to be attendant | |||
| propelled when attached to a manual wheelchair frame | Free Wheel Mode which disables the drive motors allow the device to be attendant | |||
| propelled 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 manual | |||
| wheelchair configuration | The AMP may be removed and the host wheelchair restored to its manual wheelchair | |||
| configuration | 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( |