(142 days)
Not Found
No
The description focuses on standard powered wheelchair components and control mechanisms (joystick, sip-n-puff) and does not mention any AI or ML capabilities. The performance studies are standard tests for powered wheelchairs.
No.
A therapeutic device is typically involved in the treatment or diagnosis of a condition. This device provides mobility, which addresses a need but does not directly treat or diagnose a medical condition.
No
The device description and intended use clearly state that the CHOICE powered wheelchair is for providing mobility to individuals with lower extremity impairments. There is no mention of it being used to diagnose any medical conditions.
No
The device description clearly outlines numerous hardware components including a steel frame, batteries, motors, gearboxes, actuators, and a battery charger. While it mentions software within the controller, the device is fundamentally a physical powered wheelchair.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility for individuals with physical limitations affecting their lower extremities. This is a therapeutic and assistive function, not a diagnostic one.
- Device Description: The description details the mechanical and electrical components of a powered wheelchair. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a person's health status based on such analysis.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as reagents, assays, sample handling, or diagnostic results.
In summary, the CHOICE powered wheelchair is a medical device designed for mobility assistance, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The CHOICE powered wheelchair is intended to provide mobility for a person who, due to medical reasons, the debilitating nature of some illnesses, because of accident, injury and/or subsequent paralysis, is either missing or unable to use the lower extremities. Some, but not all of the specific indications for use of a power wheelchair are: paraplegia, quadriplegia. ALS, muscular dystrophy, muscular sclerosis, lower limb amputation and any one or more of numerous neurological or muscular diseases which render the limbs too weak or unstable for normal use.
Product codes (comma separated list FDA assigned to the subject device)
89 ITI
Device Description
The CHOICE powered wheelchair is manufactured using fabricated steel for the power base and seat assemblies. All components determined to be a permanent part of the structural frame or seating are welded. Any parts which are required to be removable for service or adjustment to perform it's function are attached with locking fasteners.
The CHOICE is supplied with two, 12 volt gel cell batteries, either Group 22, Group 24 or Group 27 with a #891 style post, wired in series to provide 24 volts DC [Vortex Batteries, Doraville, GA]. The controller of the device is completely manufactured, tested and certified by Penny & Giles, Dorset, UK, which also contains the software programming and power output to operate the chair's drive motors, as well as interface to various optional features. A joystick, 'sip-n-puff', or alternative control mechanism is used to direct the function of the controller. Two drive motors are located on the power base and attached to a gearbox which provides the appropriate speed control and torque for the chair through a direct drive to the drive wheels.
Electrically controlled actuators are used to provide the various movement features of the seating system, including: reduced-shear recline, power elevating leg rests, 'tilt-in-space' and seat elevation. The chair is recharged overnight using a dual-mode, fully automatic battery charger [Lester Electrical, Lincoln, NE Model Number 24EL8, 120V/60Hz] certified for safety and fire resistance in compliance with current ANSI/RESNA standards.
The CHOICE is available with either a 16- or 18-inch wide base in combination with seats widths from 14- to 20-inches and seat depths from 14- to 24-inches to accommodate most users.
The CHOICE is available as a basic, powered wheelchair with a fixed seat, or with any or all of the following seating and positioning options:
- . seat elevator providing 8 to 10 inches of vertical lift
- . reduced-shear recliner, with or without power elevating leg rests
- . 'Tilt-in-Space', 0 to 55 degrees
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Nonclinical Tests:
- Study Type: Testing in accordance with ANSI/RESNA Standard, Wheelchairs - Testing of Power and Control Systems for Electric Wheelchair, WC/14, December 1991, parts 00, 01, 02, 03, 05 and 10.
- WC 01: Static Stability Test Results (downhill, uphill, sideways stability; various block sizes and seat positions)
- WC 02: Dynamic Stability Test Results (up ramp with max. acceleration, braking down 5 deg., turning)
- WC 03: Stopping Distances from Maximum Speed Maximum Effort (Max) and Automatic (Auto) Braking
- WC 05: Overall Dimensions (length, width, height, turning radius, turnaround width)
- WC 10: Obstacle Climbing Test Results (forward/backward; no run-up/20 inch run-up)
- Study Type: Testing for compliance to ANSI/RESNA "Proposal, Addition to ANSI/RESNA WC/14 - Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters', Ver. 1.5; 1/11/94.
- Study Type: Testing for compliance to Electromagnetic Compatibility for Industrial Process Measurement and Control Equipment.
- Key Results: The CHOICE was found to be fully compliant with the EMC specification requirements with a test level of 40 V/m and meets or exceeds all requirements of the test specification. The detailed tables for WC 01, WC 02, WC 03, WC 05, and WC 10 show specific measurements and stability/stopping/dimension results.
Clinical Tests:
- Study Type: No clinical tests were submitted.
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.
EXCELSIOR SR powered wheelchair, K900330, K940051
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
§ 890.3860 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).
0
AMERICAN MEDICAL TECHNOLOGIES, INC.
COMPASSION ● DEDICATION ● INNOVATION
510(k) Summary K962808
- (a) (1) Submitter's name, address American Medical Technologies, Inc. 160 Lee Street Canton, Georgia 30114
Contact Person J.R. McLaughlin Vice President. Operations (770) 479-1695
FEB 1 3 1997
Date of preparation of this summary: 14 September 1996
- Device trade or proprietary name: (2)
CHOICE Powered Wheelchair
Device common or usual name or classification name
| Product Nomenclature | Classification Number | Class | Panel |
|---|---|---|---|
| WHEELCHAIR, POWERED | 89 ITI | II PHYSICAL MEDICINE |
Substantial Equivalence (3)
The CHOICE powered wheelchair is substantially equivalent in safety, efficacy, technology and intended use to its predicate model EXCELSIOR SR powered wheelchair currently marketed by American Medical Technologies as well as numerous other devices such as the Permobil, Inc. 'Chairman' power wheelchair, the Sunrise Medical 'Quickie P300' power wheelchair [K900330] and the Invacare 'Action Storm' power wheelchair [K940051].
Description of the new device (4)
The CHOICE powered wheelchair is manufactured using fabricated steel for the power base and seat assemblies. All components determined to be a permanent part of the structural frame or seating are welded. Any parts which are required to be removable for service or adjustment to perform it's function are attached with locking fasteners.
The CHOICE is supplied with two, 12 volt gel cell batteries, either Group 22, Group 24 or Group 27 with a #891 style post, wired in series to provide 24 volts DC [Vortex Batteries, Doraville, GA]. The controller of the device is completely manufactured, tested and certified by Penny & Giles, Dorset, UK, which also contains the software programming and power output to operate the chair's drive motors, as well as interface to various optional features. A joystick, 'sip-n-puff', or alternative control mechanism is used to direct the function of the controller. Two drive motors are located on the power base and attached to a gearbox which provides the appropriate speed control and torque for the chair through a direct drive to the drive wheels.
Electrically controlled actuators are used to provide the various movement features of the seating system, including: reduced-shear recline, power elevating leg rests, 'tilt-in-space' and seat elevation. The chair is recharged overnight using a dual-mode, fully automatic battery charger [Lester Electrical, Lincoln, NE Model Number 24EL8, 120V/60Hz] certified for safety and fire resistance in compliance with current ANSI/RESNA standards.
1
Intended use of the device. (ર)
The CHOICE powered wheelchair is intended to provide mobility for a person who, due to medical reasons, the debilitating nature of some illnesses, because of accident, injury and/or subsequent paralysis, is either missing or unable to use the lower extremities. Some, but not all of the specific indications for use of a power wheelchair are: paraplegia, quadriplegia. ALS, muscular dystrophy, muscular sclerosis, lower limb amputation and any one or more of numerous neurological or muscular diseases which render the limbs too weak or unstable for normal use.
Technological characteristics of the device. (6)
Sizes, configurations and functions of each device component
The CHOICE is available with either a 16- or 18-inch wide base in combination with seats widths from 14- to 20-inches and seat depths from 14- to 24-inches to accommodate most users.
The CHOICE is available as a basic, powered wheelchair with a fixed seat, or with any or all of the following seating and positioning options:
- . seat elevator providing 8 to 10 inches of vertical lift
- . reduced-shear recliner, with or without power elevating leg rests
- . 'Tilt-in-Space', 0 to 55 degrees
Both tilt and recline are used to provide pressure relief and, can be used either in combination or independently as necessary.
The elevator feature provides many vocational and functional benefits associated with position. While not providing any physically therapeutic benefit, the practical value tends to make this feature very desirable for those persons with enough use of arms and hands.
Specifications
Weight: 199 lb. w/o batteries, 270 to 300 lb. with batteries Length: 34 inches, plus footrest Height: 19.5 inches, floor to seat Overall Width: customized, from 26 to 28 inches Seat Width: customized, from 14 to 22 inches Front Wheels: 14" OD x 3" wide Rear Wheels: 8" OD x 2" wide
2
(b) (1) Summary of nonclinical tests submitted with the premarket notification for the device.
The CHOICE was tested in accordance with the ANSI/RESNA Standard, Wheelchairs -Testing of Power and Control Systems for Electric Wheelchair. WC/14, December 1991, parts 00, 01, 02, 03, 05 and 10:
WC 01: Static Stability Test Results
| Test Number | 7.1 | 7.1 | 7.2 | 7.3 | ||||
|---|---|---|---|---|---|---|---|---|
| Chair position | Downhill | Uphill | Uphill | Sideways | ||||
| Wheel locks | locked | locked | unlocked | locked | ||||
| Action | Slide | Tip | Slide | Tip | Tip | Slide | Tip | |
| Block Size | 0" | 1.6" | 0" | 0" | 1.6" | 3.9" | 0" | 1.6" |
| seat postion | ||||||||
| fully down | no slide | 17.5° | 18° | 43° | 49° | 22° | 35° | |
| seat position | ||||||||
| fully up | no slide | 12° | 18° | 43° | 49° | 19° | 26° |
WC 02: Dynamic Stability Test Results
| Test Number | 7.1 | 7.2 | 7.3 |
|---|---|---|---|
| description | Up ramp with | ||
| max.accelleration | Braking down 5 deg. | ||
| [lift, tip, slide, stable] | Turning | ||
| [lift, tip or stable] | |||
| seat position | |||
| fully down | 22° to lift | ||
| unit is front-wheel-drive | stable. unit is equipped | ||
| with anti-tip devices | stable. unit is equipped | ||
| with anti-tip devices | |||
| seat position | |||
| fully up | 19° to lift | ||
| unit is front-wheel-drive | stable. unit is equipped | ||
| with anti-tip devices | stable. unit is equipped | ||
| with anti-tip devices |
WC 03: Stopping Distances from Maximum Speed Maximum Effort (Max) and Automatic (Auto) Braking
| Test Number | 7.2.1a | 7.2.1b | 7.2.1c | ||||
|---|---|---|---|---|---|---|---|
| Maximum Speed | |||||||
| (mph) | Forward, Horizontal | ||||||
| Plane (feet) | Backward, Horiz. | ||||||
| Plane (feet) | Forward, down 5 | ||||||
| Incline (feet) | |||||||
| Forward | Reverse | Max | Auto | Max | Auto | Max | Auto |
| 5.2 | 1.3 | 3.3 | 3.8 | 2.3 | 2.8 | 3.3 | 3.8 |
WC 05: Overall Dimensions
| 5.1.1 | 5.1.2 | 5.1.3 | 5.1.4 | ||||
|---|---|---|---|---|---|---|---|
| Overall length with | |||||||
| leg support | |||||||
| and footrest | Overall length without | ||||||
| leg support | |||||||
| and footrest | Overall width | Overall height with | |||||
| backrest in upright | |||||||
| position | |||||||
| inches | mm | inches | mm | inches | mm | inches | mm |
| 45 | 1143 | 31.5 | 800 | 26 | 660 | 41 | 1041 |
3
| 7.1 | 7.2 | ||
|---|---|---|---|
| Turning radius | Turnaround width | ||
| between limiting | |||
| walls | |||
| inches | mm | inches | mm |
| 24 | 610 | 44 | 1118 |
WC 05; Overall Dimensions (turning space)
WC 10: Obstacle Climbing Test Results
| 7.1
Forward
no run-up | | 7.2
Backward
no run-up | | 7.3
Forward
20 inch run-up | | 7.4
Backward
20 inch run-up | |
|-----------------------------|-------|------------------------------|----|----------------------------------|----|-----------------------------------|----|
| inches | mm | inches | mm | inches | mm | inches | mm |
| 2.25 | 57.15 | 2.25 | 57 | 3 | 76 | 2.25 | 57 |
Additionally, the CHOICE was tested in accordance with the ANSI/RESNA "Proposal, Addition to ANSI/RESNA WC/14 - Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters', Ver. 1.5; 1/11/94 to conclude that the CHOICE is fully compliant with the EMC specification requirements with a test level of 40 V/m.
The CHOICE was also tested for compliance to the specification, Electromagnetic Compatibility for Industrial Process Measurement and Control Equipment, also related to the above ANSI/RESNA Proposal to determine that the CHOICE meets or exceeds all requirements of the test specification.
(b) (2) Summary of clinical tests submitted with the premarket notification for the device.
No clinical tests were submitted with the pre-market notification for the CHOICE Powered Wheelchair.
(b) (3) Conclusions drawn from the clinical and nonclinical trials.
Analysis of the comparison of design, function and features of the CHOICE Powered Wheelchair to other devices currently legally marketed for the same intended use, together with the results of testing conducted to assess the CHOICE's compliance with existing ANSI/RESNA standards for powered wheelchairs demonstrates the CHOICE to be substantially equivalent to these predicate devices in terms of safety, efficacy, intended use and technology.