(164 days)
Not Found
No
The device description focuses on mechanical and electrical components for elevation, with no mention of AI or ML for control, analysis, or decision-making.
No
The "E-2000 Power Tilt Seating System" is an elevating system designed to provide physical assistance and improve accessibility for individuals with certain physical limitations. The document explicitly states, "Accelerated Rehab designs makes no claims as to the therapeutic effectiveness of the product(s) listed." This indicates that the device is not intended for the treatment, diagnosis, cure, or prevention of disease, which are typically hallmarks of a therapeutic device.
No
The E-2000 Power Tilt Seating System is an elevating system designed to help individuals with physical limitations reach items that were previously unreachable. It is a mobility aid, not a device used to identify, measure, or monitor a medical condition.
No
The device description explicitly details hardware components such as a motion system, ball drive tower actuator, brackets, mounting hardware made from aluminum and steel, and a toggle switch for activation. It is a physical elevating seat system for wheelchairs, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The "E-2000 Power Tilt Seating System" is a mechanical system designed to elevate a wheelchair seat. Its purpose is to improve accessibility for individuals with physical limitations.
- Lack of Biological Sample Analysis: The device does not interact with or analyze any biological samples from the patient.
- Focus on Physical Function: The intended use and device description clearly focus on enhancing the user's physical ability to reach objects and interact with their environment.
The device is a mobility aid, specifically an accessory for a wheelchair, and falls under the category of medical devices, but not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The "E-2000 Power Tilt Seating System" is an elevating system utilizing the wheelchair manufactures existing tubular seating system with armrests, front rigging, back assembly, and optional accessories.
The Elevating Seat System attaches to the wheelchair base frame and seat frame. By activation of the supplied switch, the system will elevate up to eight (8) inches from its lowest position.
The E-2000 Power Elevating Seat System allows the customer the availability to reach items that in the past, were unreachable to them due to their physical limitations. In the home, the overhead kitchen cabinets are now accessible. In the workplace, the availability of reaching the upper drawers of file cabinets without help from others. Having the ability to interact with fellow students on their level, within the school setting. Some of the customers that may benefit from the use of the E-2000 System are customers with a diagnosis of , but not limited to:
- Muscular Dystrophy (MD) .
- . Multiple Sclerosis (MS)
- Spinal Cord Injury (SCI) .
- Amyotrophic Lateral Sclerosis (ALS) ◆
Accelerated Rehab designs makes no claims as to the therapeutic effectiveness of the product(s) listed. Accelerated Rehab Designs recommends that an accredited rehabilitation therapist and supplier evaluate all customers of its products.
The above indications for use are identical to those of Mechanical Application Designs, Inc Liftmaster System in which we are claiming substantial equivalence.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
THE ACCELERATED REHAB DESIGNS, INC "E-2000 POWER ELEVATING SEAT SYSTEM" CONSISTS OF A MOTION SYSTEM, BALL DRIVE TOWER ACTUATOR WITH A LOAD CAPACITY OF 500 POUNDS. THE SYSTEM BRACKETS AND MOUNTING HARDWARE MATERIALS ARE DESIGNED AND MANUFACTURED FROM ALUMINUM AND STEEL. THE E-2000 SYSTEM HAS A BEGINNING SEAT TO FLOOR HEIGHT OF 18 % INCHES, AND WILL ELEVATE 8 INCHES TO AN UPPER LIMIT OF 26 % INCHES. CUSTOM SEAT TO FLOOR HEIGHTS WILL BE AVAILABLE UPON REQUEST WITH A MAXIMUM ELEVATION OF 28 1/2" INCHES.
THE E-2000 ELEVATING SEAT SYSTEM HAS A WEIGHT LIMIT OF 250 POUNDS, OR THE WHEELCHAIR MANUFACTURES BASE FRAME WEIGHT LIMIT. WHICH EVER IS LOWER. ACCELERATED REHAB DESIGNS WILL NOT EXCEED THE WHEELCHAIR MANUFACTURES BASE FRAME LIMIT.
THE E-2000 SYSTEM IS DESIGNED TO BE DRIVEN IN THE LOWERED POSITION. THERE ARE CERTAIN CIRCUMSTANCES THAT MAY ARRISE THAT A CUSTOMER NEEDS TO DRIVE IN THE ELEVATED POSITION. THIS MAY BE AT WORK, HOME, OR IN THE SCHOOL SETTING. THE WHEELCHAIRS ELECTRONICS ARE TO BE PROGRAMMED TO A VERY SLOW DRIVING SPEED WHILE IN THE ELEVATED POSITION. IF IT IS FELT BY THE REHAB PROFESSIONAL THAT A CUSTOMER SHOULD NOT DRIVE WHILE ELEVATED, A MAGNETIC SWITCH DRIVE LOCKOUT IS INSTALLED. ONCE THE CUSTOMER BEGINS TO ELEVATE, THE WHEELCHAIRS DRIVE CONTROLS ARE DISABLED. ONCE BACK IN THE LOWER POSITION, THE CHAIR MAY BE DRIVEN AGAIN.
BY DESIGN, THE E-2000 SYSTEM WILL ALLOW CUSTOM SEATING SYSTEMS TO BE MOUNTED. THE SYSTEM IS ACTIVATED BY THE USE OF A LOW-AMP DUAL DIRECTION TOGGLE SWITCH.
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
Home, work, or school setting. A rehabilitation therapist and supplier are recommended to evaluate customers.
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): 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.
Mechanical Application Designs, Inc: Liftmaster K972563
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
992828
FEB 3 2000
195 per 195
"510K SUMMARY"
| SUBMITER: | Accelerated Rehab Designs, Inc.
32025 Industrial Park Drive
Pinehurst, Texas 77362
Phone: (281) 356-1950
Fax: (281) 356-1903
Email: ard@ev1.net |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Randall Potter |
| DATE: | 08/18/99 |
| NAME OF DEVICE: | E-2000 Power Elevating Seat System |
| TRADE NAME: | E-2000 Power Elevating Seat System |
| COMMON NAME: | Power Elevating Seat System |
| CLASSIFICATION NAME: | Physical Medicine / Wheelchair, Powered |
| PRODUCT CODE: | ITI |
| REGULATION No: | 890.3930 |
| TYPE: | Traditional |
| SUBSTANCIAL EQUIVALENCE: | Mechanical Application Designs, Inc: Liftmaster K972563 |
1
129 2050
DESCRIPTION: THE ACCELERATED REHAB DESIGNS, INC "E-2000 POWER ELEVATING SEAT SYSTEM" CONSISTS OF A MOTION SYSTEM, BALL DRIVE TOWER ACTUATOR WITH A LOAD CAPACITY OF 500 POUNDS. THE SYSTEM BRACKETS AND MOUNTING HARDWARE MATERIALS ARE DESIGNED AND MANUFACTURED FROM ALUMINUM AND STEEL. THE E-2000 SYSTEM HAS A BEGINNING SEAT TO FLOOR HEIGHT OF 18 % INCHES, AND WILL ELEVATE 8 INCHES TO AN UPPER LIMIT OF 26 % INCHES. CUSTOM SEAT TO FLOOR HEIGHTS WILL BE AVAILABLE UPON REQUEST WITH A MAXIMUM ELEVATION OF 28 1/2" INCHES.
THE E-2000 ELEVATING SEAT SYSTEM HAS A WEIGHT LIMIT OF 250 POUNDS, OR THE WHEELCHAIR MANUFACTURES BASE FRAME WEIGHT LIMIT. WHICH EVER IS LOWER. ACCELERATED REHAB DESIGNS WILL NOT EXCEED THE WHEELCHAIR MANUFACTURES BASE FRAME LIMIT.
THE E-2000 SYSTEM IS DESIGNED TO BE DRIVEN IN THE LOWERED POSITION. THERE ARE CERTAIN CIRCUMSTANCES THAT MAY ARRISE THAT A CUSTOMER NEEDS TO DRIVE IN THE ELEVATED POSITION. THIS MAY BE AT WORK, HOME, OR IN THE SCHOOL SETTING. THE WHEELCHAIRS ELECTRONICS ARE TO BE PROGRAMMED TO A VERY SLOW DRIVING SPEED WHILE IN THE ELEVATED POSITION. IF IT IS FELT BY THE REHAB PROFESSIONAL THAT A CUSTOMER SHOULD NOT DRIVE WHILE ELEVATED, A MAGNETIC SWITCH DRIVE LOCKOUT IS INSTALLED. ONCE THE CUSTOMER BEGINS TO ELEVATE, THE WHEELCHAIRS DRIVE CONTROLS ARE DISABLED. ONCE BACK IN THE LOWER POSITION, THE CHAIR MAY BE DRIVEN AGAIN.
BY DESIGN, THE E-2000 SYSTEM WILL ALLOW CUSTOM SEATING SYSTEMS TO BE MOUNTED. THE SYSTEM IS ACTIVATED BY THE USE OF A LOW-AMP DUAL DIRECTION TOGGLE SWITCH.
INTENDED USE: THE E-2000 ELEVATING SEAT SYSTEM DESIGN IS INTENDED FOR USE ON POWER AND MANUAL WHEELCHAIRS. THE SYSTEM WILL ELEVATE CUSTOMERS ABOVE THAT OF THE STANDARD WHEELCHAIR SEAT TO FLOOR HEIGHT. IT ALLOWS THE CUSTOMER TO ACCESS AREAS, WITHOUT THE AID OF AN ATTENDANT THAT HAVE BEEN OUT OF THEIR REACH DUE TO THE STANDARD WHEELCHAIR SEAT TO FLOOR HEIGHT.
TECHNOLOGICAL CHARACTERISTICS: ALTHOUGH SIMILAR IN DESIGN, THE MECHANICAL APPLICATION DESIGNS, TILTMASTER SYSTEM ONLY MOUNTED TO THE INVACARE STORM SERIES BASE FRAME, MAKING THE SELECTION OF WHEELCHAIR BASE FRAMES LIMITING TO THE CUSTOMER. THE E-2000 SYSTEM WILL BE AVAILABLE ON NUMEROUS WHEELCHAIR BASE FRAMES.
HE TILTMASTER SYSTEM WAS REQUIRED TO BE INSTALLED AT THE TILTMASTER MANUFACTURING FACILITY. THE E-2000 SYSTEM IS A DEALER INSTALLATION. ACCELERATED REHAB DESIGN INSTALLATION IS AVAILABLE UPON REQUEST.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three abstract human figures or shapes, arranged in a row.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2000 FEB
Mr. Randall Potter President Accelerated Rehab Designs, Inc. 32025 Industrial Park Drive Pinehurst, Texas 77362
Re: K992828
Trade Name: E-2000 Power Elevating Seat System, Models ARD-ESTORM Regulatory Class: II Product Code: ITI Dated: Undated Received: December 28, 1999
Dear Mr. Potter:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
3
Page 2 – Mr. Randall Potter
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mala M Millan
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): _____________________________________________________________________________________________
E-2000 POWER ELEVATING SEAT SYSTEM Device Name:
Indications For Use:
The "E-2000 Power Tilt Seating System" is an elevating system utilizing the wheelchair manufactures existing tubular seating system with armrests, front rigging, back assembly, and optional accessories.
The Elevating Seat System attaches to the wheelchair base frame and seat frame. By activation of the supplied switch, the system will elevate up to eight (8) inches from its lowest position.
The E-2000 Power Elevating Seat System allows the customer the availability to reach items that in the past, were unreachable to them due to their physical limitations. In the home, the overhead kitchen cabinets are now accessible. In the workplace, the availability of reaching the upper drawers of file cabinets without help from others. Having the ability to interact with fellow students on their level, within the school setting. Some of the customers that may benefit from the use of the E-2000 System are customers with a diagnosis of , but not limited to:
- Muscular Dystrophy (MD) .
- . Multiple Sclerosis (MS)
- Spinal Cord Injury (SCI) .
- Amyotrophic Lateral Sclerosis (ALS) ◆
Accelerated Rehab designs makes no claims as to the therapeutic effectiveness of the product(s) listed. Accelerated Rehab Designs recommends that an accredited rehabilitation therapist and supplier evaluate all customers of its products.
The above indications for use are identical to those of Mechanical Application Designs, Inc Liftmaster System in which we are claiming substantial equivalence.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of General Restorative Devices |
| 510(k) Number | K992828 |
|---|---|
| --------------- | --------- |
| Prescription Use: | OR Over-The-Counter Use: |
|---|---|
| ------------------- | ----------------------------------------------------------------------------------- |
(Optional Format 1-2-96)
Revised 11/13/1998
(Pre 21 CFR 801.109)