(290 days)
Not Found
No
The description focuses on standard power wheelchair components and control systems, with no mention of AI or ML capabilities. The "fully programmable control system" and "sophisticated diagnostics" are described in terms of traditional control logic and monitoring, not AI/ML algorithms.
No.
The device, a power wheelchair, is described as aiding mobility, not as providing therapy or treatment for a medical condition. While it helps individuals with limited lower extremity use, its primary function is assistive mobility, not therapeutic intervention.
No
The device is a power wheelchair, described as providing mobility and having safety features. While it mentions "sophisticated diagnostics to facilitate repair," this refers to diagnosing issues with the wheelchair itself, not diagnosing medical conditions of a user. Its intended use is to promote mobility for individuals lacking full use of their lower extremities, not to diagnose a medical condition.
No
The device description clearly outlines numerous hardware components including a frame, motors, batteries, controller, and wheels, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "promote mobility" for individuals lacking full use of their lower extremities. This is a functional purpose related to physical movement, not the diagnosis of a disease or condition.
- Device Description: The description details a mechanical and electrical device designed for transportation and mobility. It involves motors, wheels, a frame, and controls for movement. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of analytes (substances in the body).
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly a mobility aid, specifically a powered wheelchair, designed to assist individuals with physical limitations.
N/A
Intended Use / Indications for Use
The specific intended use of the power wheelchair, which is the subject device, is identical to pre-existing or predicate devices. I.H.S. CHIPS POWER CHAIR helps promote mobility, both indoors, for the intended user commonly lacking full use of lower extremities. This limited use could be of short or long duration and caused by numerous medical conditions, ranging from spinal cord injuries to temporary broken bones in a lower extremity.
Product codes
Not Found
Device Description
Powered Wheelchair. The device provides mobility by incorporating a joy stick type controller which sends power to electric gear motors, which in turn are directly driving two rear wheels which propel the device. The controller incorporates safety features such as, speed control, sensitivity control, battery life indicator and power on and off indicator light. The main product components include a steel tubular welded frame which supports a sitting surface. Both the seat and the back support are made of a durable nylon material. The frame incorporates adjustable and removable armrests. Both leg rests and foot rests are designed to be fully adjustable to accommodate a variety of anatomical differences and are designed to swing away to facilitate entry and exit and are removable for transportation. Power is supplied by two 12 volt wet or gel cell batteries providing a 24 volt system. This supplies power to two rear mounted direct drive motors, both incorporating electromechanical automatic brakes. The motors provide power to a sealed gear box which transfers power to the rear wheels. The fully programmable control system provides reliable, precise control and conforms to the latest International Standards. It handles currents from 20 Amps per channel, is fully programmable, incorporates true charge battery level indicator, has user speed and response controls, and a horn. It incorporates sophisticated diagnostics to facilitate repair and provides speed stability on slopes for safety. It incorporates hand tremor dampening for users who have poor motor control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Rehabilitation dealer (who instructs the end user) / indoors
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests were performed and described in Section 4 - Technical Specifications and Test Reports. The device has been manufactured to meet or exceed ISO 9001 and designed to ISO 7176/14 and has been approved by International Regulations known as TUV and has surpassed Swedish Handicap Institute Approval. (All Test Criteria - Please Refer to Sections 4 and 5).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Invacare Corp., trade name, . Action, located at 899 Cleveland Street, Elyria, Ohio 44035, Sunrise Medical, trade name, Quickie, located at 2842 Business Park Ave., Fresno, CA 93727-1328, and 21st Century Scientific Inc., trade name, Bounder, located at 4915 Industrial Way, Coeur d'Alene, ID 83814.
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).
0
Image /page/0/Picture/0 description: The image shows a logo for I.H.S. International. The text "I.H.S. INTERNATIONAL" is written in a bold, sans-serif font. Below the text is a stylized image of the world, with the continents outlined in black and the oceans represented by a grid of lines. The logo is simple and professional, and it conveys a sense of global reach.
HEALTHCARE SOLUTIONS, INC.
Image /page/0/Picture/2 description: The image shows the text "SEP 20 1988". The text is in a bold, sans-serif font. The letters and numbers are all capitalized. The text is likely part of a date, with "SEP" being an abbreviation for September, "20" being the day of the month, and "1988" being the year.
510(K) SUMMARY Powered Wheelchair
November 29, 1995
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
- . Name of Device: Wheelchair, Powered
- Proprietary Name: CHIPS Powered Wheelchair
- Common Name : Powered Wheelchair .
- . Classification Name: Wheelchair, Powered
- Legally marketed device to which our company is claiming equivalence: Invacare Corp., trade name, . Action, located at 899 Cleveland Street, Elyria, Ohio 44035, Sunrise Medical, trade name, Quickie, located at 2842 Business Park Ave., Fresno, CA 93727-1328, and 21st Century Scientific Inc., trade name, Bounder, located at 4915 Industrial Way, Coeur d'Alene, ID 83814.
- . Description of Device: Powered Wheelchair. See attached letter
- Intended Use of Device: See attached description letter. .
- . Summary of technological characteristics of our device compared to the predicate device: Refer to Section 4 - Technical Specifications and Test Reports.
- Brief description of the nonclinical tests and how their results support a determination of substantial . equivalence: Refer to, Section 4 - Technical Specifications and Test Reports.
Very truly yours.
Paul Witz
Fred DiVito President
1
Image /page/1/Picture/0 description: The image shows a logo for I.H.S. International. The logo features the text "I.H.S. INTERNATIONAL" in a curved, bold font at the top. Below the text is a black and white illustration of the world, depicted as a grid of lines forming the continents and oceans. The overall design is simple and classic, with a focus on the global reach of the organization.
HEALTHCARE SOLUTIONS, INC.
CHIPS POWER WHEELCHAIR DESCRIPTIVE INFORMATION
510(K) Pre Market Notification
The specific intended use of the power wheelchair, which is the subject device, is identical to pre-existing or predicate devices.
I.H.S. CHIPS POWER CHAIR helps promote mobility, both indoors, for the intended user commonly lacking full use of lower extremities. This limited use could be of short or long duration and caused by numerous medical conditions, ranging from spinal cord injuries to temporary broken bones in a lower extremity.
Our subject device provides mobility by incorporating a joy stick type controller which sends power to electric gear motors, which in turn are directly driving two rear wheels which propel the device.
This is very typical and common to predicate devices like those manufactured by Sunrise Medical, 2842 Business Park Avenue, Fresno, CA 93727 and Invacare, 899 Cleveland Street, Elyria, OH 44036. (Refer to Section 3 for details).
The controller on the subject device, similar to predicate devices, incorporates safety features such as, speed control, sensitivity control, battery life indicator and power on and off indicator light.
The above controller features are typically customized by the rehabilitation dealer, who has been instructed in the use and function of the product and who in turn instructs the end user in the use and function of the power chair. (Refer to Section 4 for details).
The main product components include a steel tubular welded frame which supports a sitting surface. (Refer to Section 4 for details).
Both the seat and the back support are made of a durable nylon material. In addition, the frame incorporates adjustable and removable armrests, providing support for the user, and is removable to facilitate transfer into and out of the wheelchair.
Both leg rests and foot rests are designed to be fully adjustable to accommodate a variety of anatomical differences.
All leg rests and foot rests assembly are designed to swing away to facilitate entry and exit to the power chair and are removable to facilitate transportation of the device.
All of the above described features are typical and common in predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for I.H.S. International. The text "I.H.S. INTERNATIONAL" is at the top of the logo. Below the text is a black and white image of the world.
HEALTHCARE SOLUTIONS, INC.
- 2 -
CHIPS POWER WHEELCHAIR (cont. )
Power is supplied to the device by incorporating two 12 volt wet or gel cell batteries providing a 24 volt system. This in turn supplies power to two rear mounted direct drive motors, both incorporating electromechanical automatic brakes. The motors in turn provide power to a sealed gear box which transfers power to the rear wheels.
The fully programmable control system provides reliable, precise control and conforms to the latest International Standards. It has plenty of drive to cope with curbs or hill climbing by continually monitoring motor voltage and current. It readily maintains constant speed over demanding uneven terrain and prevents unwanted rolling on slopes. It handles currents from 20 Amps per channel, is fully programmable, incorporates true charge battery level indicator, has user speed and response controls, and a horn to alert others. (Refer to Sections 4 and 5 for details).
It incorporates sophisticated diagnostics to facilitate repair and provides speed stability on slopes for safety.
It incorporates hand tremor dampening for users who have poor motor control.
It has been manufactured to meet or exceed ISO 9001 and design to ISO 7176/14 and has been approved by International Regulations known as TUV and has surpassed Swedish Handicap Institute Approval. (All Test Criteria - Please Refer to Sections 4 and 5).
Edak Ontto
pre.
Fred Di Vito November 29, 1995