(40 days)
No
The description details a purely mechanical wheelchair with no mention of any computational or intelligent features.
No.
The intended use of the device is to transport occupants who are immobile, which is a functional aid, not a therapeutic treatment for a medical condition.
No
Explanation: The device described is a mechanical wheelchair designed for transportation, not for diagnosing medical conditions. Its function is to assist immobile individuals with mobility, not to detect, monitor, or analyze any health parameters.
No
The device description clearly details a physical, mechanical wheelchair made of steel and other materials, with no mention of software as a component or the primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "transport occupants who are immobile from one location to another." This is a mechanical function for mobility, not a diagnostic test performed on biological samples.
- Device Description: The description details the physical components of a wheelchair (frame, wheels, seat, rigging) and how it is propelled. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Detecting or measuring specific substances (analytes).
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on laboratory testing.
This device is clearly a medical device for mobility assistance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The above referenced device is a lightweight mechanical wheelchair used by those who are immobile to transport from one location to another. This device submitted for FDA review and is equivalent to Everest and Jennings Lightning Wheelchair. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
OUR ELITE LIGHTWEIGHT WHEELCHAIR IS A MBCHANICAL DEVICE THAT TRANSPORT OCCUPANTS WHO ARE INMOBILE FROM ONE LOCATION TO ANOTHER. IN ORDER FOR ONE TO OPERATE THIS DEVICE AN ASSISTANT CAN PUSH THE WHEELCHAIR FROM BEHIND USING THE HANDLE BARS OR IF THE OCCUPANT HAS FUNCTION OF HIS/HER UPPER DORSO THEY CAN WHEEL THENSELVES AROUND BY USING THE HANDRIMS THAT IS ATTACHED TO THE WHEELS.
Product codes
IOR
Device Description
The frame of our Elite wheelchair is made from a high strength tensile steel called chromaly which is 28% lighter then the usual standard chrome-plated frame wheelchairs. The frame of the wheelchair is coated with a durable powder coated finish of blue, burgandy or black. It is a rigid frame that comes in two different arm styles: Fixed Full Length or Removable Wrap-Around Desk Length. Both arm styles comes with padded arms. The 24" wheels can be spoke aluminum rear wheels with pneumatic tires or mag wheels with hard rubber tires. Seat width on the wheelchair is either 18" or 16". The seat material is nylon spill proof upholstery. The rigging on the wheelchair is Cam-Action Swing Away Detachable Footrests or Detachable Elevating Legrests with calf pads that are padded for more comfort. Footplates are of aluminum material.
Dimension :
Overall Length without rigging: 31" Overall Width (opened): Between 25"-26" Overall Width (closed): Between 10.5"-11.5" Gross Weight without rigging: Between 29-30.5 Ibs
Since this wheelchair is non-powered there are two ways to propel the device, 1) is to have an assistant push the wheelchair from the back where the hand grips are or 2)if the occupant has mobility with their upper half of the torso he or she can use their arms on the handrims that are attached to the 24" wheel to self-propel themselves. The wheelchair is fully assembled and is packaged in a closed position in the wheelchair box. The only assembly required is the Rigging. Following is the instruction for the rigging.
A. Swing Away Footrest: Place the rigging on the mounting post that is welded to the wheelchair and swing the footrest closed (No assembly required on this particular rigging). You will here a click which indicates the rigging is in place for use.
- B. Swing Away Elevating Legrest: See Appendix I which shows how to assemble the Elevating Legrest. To install onto the wheelchair. please follow the same procedure as the Swing Away Footrest.
As seen in Appendix II the comparison chart show the overall features of the Elite wheelchair versus the Liantning including the various styles available to the enduser.
The Elite wheelchair can travel on any hard surfaces such as carpet, tile or concrete flooring.
The maximum weight bearing capacity is 250 lbs.
A tiltover test is not applicable for the Elite wheelchair submitted for review.
Steel Material
Material Frame: CR-MO AP (Chromaly) Chemical Compositions: Chrominum 0.85%-1.25%, Carbon 0.12% - 0.18%, Magnesium 0.55% - 0.90%, Phosphorus 0.30%, Sulfur 0.30%, Silicon 0.15% - 0.35%, Molybdenum 0.15% - 0.35%.
Material Strength tests:
Tube Size: 22.2mm * 1.0mm Outside Diameter Tube: 22.16mm - 22.17mm Tube Thickness: 1.01mm - 1.03mm Tube Straightness: .07mm - . 12mm Hardness: 80.5mm - 80.0mm Elongation: 35mm - 36mm Tension Strength: 56.3mm - 56.8mm Yield Strength: 33.3mm - 33.0mm The Eddy Current test was completed on the material.
The foam on the Upholstery was tested by SGS. The test was done in compliance with California Technical Bulletin 117 1) Section A, Part I. and 2) Section D, Part II. The test results are attached. The conclusion is that the sample submitted complies with the requirements of Section A. Part 1 and Section D. Part II for resilient Cellular Materials of California Technical Bulletin 117.
Material on Wheels
-24 Rear Wheels-Material : Nylon 80%, Fiber 20%
-Property of Plastic Rims-
| Property | Test Method | Value |
|---|---|---|
| Ash Content | ******** | 20.4% |
| Izod Impact Strength(Notch, 23deg C) | ASTM D-256 | KG-CM/CM |
| Tensile Strength atBreak | ASTM D-638 | KG/cm2 |
| Flexural Strength | ASTM D-790 | KG/cm2 |
| Flexural Modulus | ASTM D-790 | KG/cm2 |
-8" Front Casters-
Material for Plastic Rim - High Impact P.P. Material for Tire - Thermoplastic Elastomers 100%
| -Property of Caster- | ||
|---|---|---|
| Property | Test Method | Value |
| Flow Rate | ASTM D-1238 | 5 g/10min |
| Density | ASTM D-792 | 0.892 g/cm3 |
| Tensile Strength atBreak | ASTM D-638 | 268 kg/cm3 |
| Elongation | ASTM D-638 | 9.8% |
| Temperature of Deform | ASTM D-648 | 83 deg C 4.6 kg/cm |
| Izod Impact Strength(23 deg C Notch) | ASTM D-256 | 9.5 kg-cm/cm |
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)
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
§ 890.3850 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
कल्याण
DEC 17 1997
Nov 7 10 01 AM *97
RECEIVED
FDA/CDRH/ODE/CHO
SECTION IV 510(k) SUMMARY of SAFETY AND EFFECTIVENESS Prepared on August 28, 1997
Submitted By: Jaken Co., Inc. 2346 E. Walnut Ave Fullerton, Ca., 92831 Contact: Samantha Lin
1
Device Identification
Trade/Propreitary Name - Elite Lightweight Wheelchair
Generic Name - wheelchair (non-powered)
Classification of the Predicate Device - Class III
Intended Use
The above referenced device is a lightweight mechanical wheelchair used by those who are immobile to transport from one location to another. This device submitted for FDA review and is equivalent to Everest and Jennings Lightning Wheelchair. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
Description of Device
The frame of our Elite wheelchair is made from a high strength tensile steel called chromaly which is 28% lighter then the usual standard chrome-plated frame wheelchairs. The frame of the wheelchair is coated with a durable powder coated finish of blue, burgandy or black. It is a rigid frame that comes in two different arm styles: Fixed Full Length or Removable Wrap-Around Desk Length. Both arm styles comes with padded arms. The 24" wheels can be spoke aluminum rear wheels with pneumatic tires or mag wheels with hard rubber tires. Seat width on the wheelchair is either 18" or 16". The seat material is nylon spill proof upholstery. The rigging on the wheelchair is Cam-Action Swing Away Detachable Footrests or Detachable Elevating Legrests with calf pads that are padded for more comfort. Footplates are of aluminum material.
Dimension :
Overall Length without rigging: 31" Overall Width (opened): Between 25"-26" Overall Width (closed): Between 10.5"-11.5" Gross Weight without rigging: Between 29-30.5 Ibs
Since this wheelchair is non-powered there are two ways to propel the device, 1) is to have an assistant push the wheelchair from the back where the hand grips are or 2)if the occupant has mobility with their upper half of the torso he or she can use their arms on the handrims that are attached to the 24" wheel to self-propel themselves. The wheelchair is fully assembled and is packaged in a closed position in the wheelchair box. The only assembly required is the Rigging. Following is the instruction for the rigging.
2
Device Description Continue
A. Swing Away Footrest: Place the rigging on the mounting post that is welded to the wheelchair and swing the footrest closed (No assembly required on this particular rigging). You will here a click which indicates the rigging is in place for use.
- B. Swing Away Elevating Legrest: See Appendix I which shows how to assemble the Elevating Legrest. To install onto the wheelchair. please follow the same procedure as the Swing Away Footrest.
As seen in Appendix II the comparison chart show the overall features of the Elite wheelchair versus the Liantning including the various styles available to the enduser.
The Lightning Wheelchair equivalent to the Premier 2 ( both are manufactured by Everest and Jennings) is a legally marketed device which has been granted marketing clearance by FDA following the submission of a 510(k) number which is K930412. Please see Appendix III for photographs and diagram of the two devices.
The Elite wheelchair can travel on any hard surfaces such as carpet, tile or concrete flooring.
The maximum weight bearing capacity is 250 lbs.
A tiltover test is not applicable for the Elite wheelchair submitted for review.
Steel Material
Material Frame: CR-MO AP (Chromaly) Chemical Compositions: Chrominum 0.85%-1.25%, Carbon 0.12% - 0.18%, Magnesium 0.55% - 0.90%, Phosphorus 0.30%, Sulfur 0.30%, Silicon 0.15% - 0.35%, Molybdenum 0.15% - 0.35%.
Material Strength tests:
Tube Size: 22.2mm * 1.0mm Outside Diameter Tube: 22.16mm - 22.17mm Tube Thickness: 1.01mm - 1.03mm Tube Straightness: .07mm - . 12mm Hardness: 80.5mm - 80.0mm Elongation: 35mm - 36mm Tension Strength: 56.3mm - 56.8mm Yield Strength: 33.3mm - 33.0mm The Eddy Current test was completed on the material.
3
Upholstery Material
The foam on the Upholstery was tested by SGS. The test was done in compliance with California Technical Bulletin 117 1) Section A, Part I. and 2) Section D, Part II. The test results are attached. The conclusion is that the sample submitted complies with the requirements of Section A. Part 1 and Section D. Part II for resilient Cellular Materials of California Technical Bulletin 117.
Material on Wheels
-24 Rear Wheels-Material : Nylon 80%, Fiber 20%
-Property of Plastic Rims-
| Property | Test Method | Value |
|---|---|---|
| Ash Content | ******** | 20.4% |
| Izod Impact Strength | ||
| (Notch, 23deg C) | ASTM D-256 | KG-CM/CM |
| Tensile Strength at | ||
| Break | ASTM D-638 | KG/cm2 |
| Flexural Strength | ASTM D-790 | KG/cm2 |
| Flexural Modulus | ASTM D-790 | KG/cm2 |
-8" Front Casters-
Material for Plastic Rim - High Impact P.P. Material for Tire - Thermoplastic Elastomers 100%
| -Property of Caster- | ||
|---|---|---|
| Property | Test Method | Value |
| Flow Rate | ASTM D-1238 | 5 g/10min |
| Density | ASTM D-792 | 0.892 g/cm3 |
| Tensile Strength at | ||
| Break | ASTM D-638 | 268 kg/cm3 |
| Elongation | ASTM D-638 | 9.8% |
| Temperature of Deform | ASTM D-648 | 83 deg C 4.6 kg/cm |
| Izod Impact Strength | ||
| (23 deg C Notch) | ASTM D-256 | 9.5 kg-cm/cm |
Labeling
Appendix IV shows sample packaging
Appendix V shows labeling on the wheelchair
Appendix VI shows Operators Instruction
4
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1997
Ms. Samantha Lin ·Jaken Company, Inc. 2346 East Walnut Avenue 92831 Fullerton, California
Re: K974197 Elite Lightweight Wheelchair Regulatory Class: I Product Code: IOR Dated: June 21, 1997 Received: November 7, 1997
Dear Ms. Lin:
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 The general controls provisions of the Act 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. ਸੈ 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 In addition, FDA may publish further announcements action. 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.
5
Page 2 - Ms. Samantha Lin
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.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known):
Device Name: _ ELITE SERIES WHEELCHAIR
Indications For Use:
OUR ELITE LIGHTWEIGHT WHEELCHAIR IS A MBCHANICAL DEVICE THAT TRANSPORT OCCUPANTS WHO ARE INMOBILE FROM ONE LOCATION TO ANOTHER. IN ORDER FOR ONE TO OPERATE THIS DEVICE AN ASSISTANT CAN PUSH THE WHEELCHAIR FROM BEHIND USING THE HANDLE BARS OR IF THE OCCUPANT HAS FUNCTION OF HIS/HER UPPER DORSO THEY CAN WHEEL THENSELVES AROUND BY USING THE HANDRIMS THAT IS ATTACHED TO THE WHEELS.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
pcolef
(Division Sign-Off) Division of General Re 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)