(164 days)
Not Found
No
The description details a mechanical wheelchair with a tilting mechanism and standard components. There is no mention of software, algorithms, or any technology that would suggest AI or ML. The testing performed is related to mechanical and structural standards.
No
A wheelchair provides mobility and support, but it does not treat or cure a disease or condition, which is the definition of a therapeutic device.
No
Explanation: The device is a manual wheelchair, which is a mobility aid. Its intended use is to provide mobility to persons restricted to a sitting position, and it does not perform any diagnostic functions.
No
The device description clearly outlines a mechanical wheelchair with physical components like a frame, wheels, upholstery, and gas cylinders. It also details physical testing performed on the device. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to persons restricted to a sitting position. This is a mechanical function related to physical support and movement, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description details a mechanical chair with wheels, designed as a replacement for walking. It focuses on physical components and their function in providing mobility.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any process related to diagnosing or monitoring a medical condition through laboratory testing.
The device is a manual wheelchair, which falls under the category of medical devices used for physical support and mobility.
N/A
Intended Use / Indications for Use
The intended use for the manual (mechanical) wheelchair is to provide mobility to persons who may be restricted to a sitting position. The manual wheelchair is intended for ongoing daily use. The models offer a wide range of customization which allows for a better fit for the end user resulting in comfort, lightweight, easier propelling, transferring, and smooth ride. The manual wheelchair is intended for indoor and outdoor use on firm surfaces free of climbing obstacles. All other uses are prohibited.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability. The device is intended for adults only.
As oppose to the standard wheelchair properties, the Supertilt Tilt main feature can tilt in space for up to 33 degrees using two gas cylinders that can support up to 250 lbs.
The components include frame, back upholstery, seat upholstery, handgrip, armrest, armrest pad, side panel.
In terms of biocompatibility, the main direct contact components on long periods in time with the user/client are the arm rest pad, cushion back cushion, headrest pad and footrest padding. Transient contacts with the user/client include arm skirt guard, arm tube, arm socket and footrest tube.
The Supertilt Plus in its final finished form is identical to the Concept 45, Invacare, K951138, cleared on 3/20/1995 (legally US marketed device) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers.
device) in formulation, processing, sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
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
The device is intended for adults only.
Intended User / Care Setting
Not Found
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 following testing was performed on the Manual Tilt Wheelchair model STP in accordance with the requirements of the design control regulations and establisthed quality assurance procedures. ISO 7176-8 - Construction ISO 7176-14:8 - Design ISO 7176-5 - Dimensions ISO 7176-1:9-12 - Stability in Least Stable Configuration ISO 7176-3:7-1 - Efficiency ANSI/RESNA WC/Vol.1:22 Annex A - Operation ISO 7176-15:7, ISO 7176-14:6.1 - Product Literature ISO 7176-7:8.3 - Angular Dimensions
Power Plus Mobility STP wheelchair was built within the standards of ANS/RESNA which involves ISO 7176. It is concluded that the STP is safe and effective as well as substantially equivalent to the predicate device.
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.
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
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".
October 28, 2022
Power Plus Mobility Jason Mohan CEO President 50 Malcom Rd Guelph, ON N1K1A9 Canada
Re: K221435
Trade/Device Name: Supertilt Plus (STP) Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: February 9, 2022 Received: May 17, 2022
Dear Jason Mohan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
SUPERTILT PLUS (STP)
Indications for Use (Describe)
The intended use for the manual (mechanical) wheelchair is to provide mobility to persons who may be restricted to a sitting position. The manual wheelchair is intended for ongoing daily use. The models offer a wide range of customization which allows for a better fit for the end user resulting in comfort, lightweight, easier propelling, transferring, and smooth ride. The manual wheelchair is intended for indoor and outdoor use on firm surfaces free of climbing obstacles. All other uses are prohibited.
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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3
510(k) Summary
Prepared on: 2022-09-13
Contact Details
21 CFR 807 92/2(1)
| Applicant Name | Power Plus Mobility |
|---|---|
| Applicant Address | 50 Malcom Rd Guelph ON N1K1A9 Canada |
| Applicant Contact Telephone | 4168091301 |
| Applicant Contact | Mr. Jason Mohan |
| Applicant Contact Email | jason@powerplusmobility.com |
Device Name 21 CFR 807.92(a)(2)
| Device Trade Name | SUPERTILT PLUS (STP) |
|---|---|
| Common Name | Mechanical wheelchair |
| Classification Name | Wheelchair, Mechanical |
| Regulation Number | 890.3850 |
| Product Code | IOR |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K951138 | Concept 45 | IOR |
Device Description Summary 21 CFR 807.92(a)(4)
A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant
turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by
people for whom walking is difficult or impossible due to illness, injury, or disability. The device is intended for adults only.
As oppose to the standard wheelchair properties, the Supertilt Tilt main feature can tilt in space for up to 33 degrees using two gas
cylinders that can support up to 250 lbs.
The components include frame, back upholstery, seat upholstery, handgrip, armrest, armrest pad, side panel.
In terms of biocompatibility, the main direct contact components on long periods in time with the user/client are the arm rest pad,
cushion back cushion, headrest pad and footrest padding. Transient contacts with the user/client include arm skirt guard, arm tube, arm
socket and footrest tube.
The Supertilt Plus in its final finished form is identical to the Concept 45, Invacare, K951138, cleared on 3/20/1995 (legally US marketed
device) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers.
device) in formulation, processing, sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The intended use for the manual (meelchair is to provide mobility to persons who may be restricted to a sitting position. The manual wheelchair is intended for ongoing daily use. The models offer a wide range of customization which allows for a better fit for the end user resulting in comfort, lightweight, easier propelling, transferring, and smooth ride. The manual wheelchair is intended for indoor and outdoor use on firm surfaces free of climbing obstacles. All other uses are prohibited.
4
| Proposed Device | Primary Predicate Device | |
|---|---|---|
| 510K Number | K221435 | K951138 |
| Product Code | IOR | IOR |
| Classification Name | Wheelchair, Mechanical | Wheelchair, Mechanical |
| Model | Supertilt Plus | Concept 45 |
| Manufacturer | Power Plus Mobility Inc. | Invacare Corporation |
| Indications for Use | The intended use for the manual (mechanical) wheelchair is to | |
| provide mobility to persons who may be restricted to a sitting | ||
| position. The manual wheelchair is intended for ongoing daily | ||
| use. The models offer a wide range of customization which | ||
| allows for a better fit for the end user resulting in comfort, | ||
| lightweight, easier propelling, transferring, and smooth ride. The | ||
| manual wheelchair is intended for indoor and outdoor use on | ||
| firm surfaces free of climbing obstacles. All other uses are | ||
| prohibited. | The intended use for the manual (mechanical) wheelchair is to | |
| provide mobility to persons who may be restricted to a sitting | ||
| position. The manual wheelchair is intended for ongoing daily | ||
| use. The models offer a wide range of customization which | ||
| allows for a better fit for the end user resulting in comfort, | ||
| lightweight, easier propelling, transferring, and smooth ride. Th | ||
| manual wheelchair is intended for indoor and outdoor use on | ||
| firm surfaces free of climbing obstacles. All other uses are | ||
| prohibited. | ||
| Basic Design | STP is a compact manual wheelchair with 2 gas cylinders that | |
| enables tilt-in-space capability, built with a steel frame on 4 | ||
| wheels, paint covered, with essential accessories as well as back | ||
| and seating upholstery. | Concept 45 is a compact manual tilt-in-space wheelchair with ar | |
| optional reclining back. | ||
| Materials | Steel (frame, armrest, caster fork, headrest frame, anti-tipper | |
| tube, rear axle), aluminum (wheel lock, footrest frame, | ||
| footplate, handrim, custom headrest ball joint), PVC (armrest | ||
| pad mount, rear wheel rim and spacers, caster rim, skirt guard), | ||
| ABS (solid seat) | Steel (frame, armrest, caster fork, rear axle, footrests, headrest | |
| frame, wheel lock) aluminum (hand rim). Other materials | ||
| undocumented | ||
| Components | Armrest | |
| Rear Axle | ||
| Rear Wheel | ||
| Caster Fork | ||
| Casters | ||
| Headrest | ||
| Back Upholstery | ||
| Seat Seat Upholstery | ||
| Footrest | Armrest | |
| Rear Axle | ||
| Rear Wheel | ||
| Caster Fork | ||
| Casters | ||
| Headrest | ||
| Back Upholstery | ||
| Seat Seat Upholstery | ||
| Footrest | ||
| Occupant Mass Group | III | III |
| Control Mode | Manual | Manual |
| Total Mass | 60 lbs (Approx.) | 55 lbs (Approx.) without front riggings |
| Weight Capacity | 250 lbs | 250 lbs |
| Overall Width | 28.45" (regular 18"x18") | 23.25" |
| Overall Length | 49.67" (with footrest), 35.39" (with no footrest and retracted | |
| spreader bar) | 44.75" | |
| Overall Height | 39.69" (no headrest), 48.16" (with headrest) | 40" |
| Seat to Floor Height | Adjustable from 12.25" to 18.25", based on various wheel | |
| configurations | Adjustable from 14.5" to 18.75" | |
| Tilt Adjustment | 0 to 33 degrees | 0 to 45 degrees |
| Recline Tilt Adjustment | 0 to 15 degrees of fixed recline adjustment | 0 to 20 degrees |
| Wheel Lock | Aluminum push or pull to lock | Push or pull to Lock |
| Front Riggings | Swingaway footrest | Swingaway footrests |
| Rear Axle | Standard (Permanent) or Quick Release | Permanent or Quick Release |
| Seat Dimensions | 18"x18" | 15"-20" |
| Brake Mechanism | Push to Lock or Pull to Lock Wheel Locks | Push to Lock or Pull to Lock Wheel Locks |
| Front and Rear Wheel Tire Dimensions | 6" Caster with 22" Rear Wheel | 7" Caster with 22"Rear Wheel |
| Minimum Curb Clearance | Not Publically Available | |
| Curb Climbing Ability | Not Publically Available | |
| Minimum Turning Radius | 83cm | Not Publically Available |
| Upholstery Material | Standard Darlex. TFK4 Waternroof at the bottom | Not Publically Available |
5
Indications for Use Comparison
The indications for use is the same as the predicate device.
Technological Comparison
The Supertilt Plus has the similar technical characteristics as the predicate device such as tilt and adjustable recline. Both devices have adjustable back angle, arm rest, headrest, as well as similar seat depths and widths.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following testing was performed on the Manual Tilt Wheelchair model STP in accordance with the requirements of the design control regulations and establisthed quality assurance procedures. ISO 7176-8 - Construction ISO 7176-14:8 - Design ISO 7176-5 - Dimensions ISO 7176-1:9-12 - Stability in Least Stable Configuration ISO 7176-3:7-1 - Efficiency ANSI/RESNA WC/Vol.1:22 Annex A - Operation ISO 7176-15:7, ISO 7176-14:6.1 - Product Literature ISO 7176-7:8.3 - Angular Dimensions
Power Plus Mobility STP wheelchair was built within the standards of ANS/RESNA which involves ISO 7176. It is concluded that the STP is safe and effective as well as substantially equivalent to the predicate device.
21 CFR 807.92(a)(5)