ELITE LIGHTWEIGHT WHEELCHAIR

K974197 · Jaken Co., Inc. · IOR · Dec 17, 1997 · Physical Medicine

Device Facts

• Record ID: K974197
• Device Name: ELITE LIGHTWEIGHT WHEELCHAIR
• Applicant: Jaken Co., Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Dec 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

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.

Device Story

Non-powered, lightweight mechanical wheelchair; frame constructed of chromaly (high-strength tensile steel) with powder-coated finish. Features rigid frame; two arm styles (fixed full length or removable wrap-around desk length); 24-inch rear wheels (spoke aluminum with pneumatic tires or mag wheels with hard rubber tires); 8-inch front casters; nylon spill-proof upholstery. Rigging includes swing-away detachable footrests or elevating legrests. Operated by patient (self-propulsion via handrims) or assistant (pushing via rear handles). Used in various environments (carpet, tile, concrete). Provides mobility for immobile occupants; facilitates transport and independence.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included material strength analysis (tension, yield, elongation, hardness), Eddy Current testing on steel, and flammability testing of upholstery per California Technical Bulletin 117. Plastic components (rims and casters) were evaluated for tensile strength, impact strength, and flow rate per ASTM standards.

Technological Characteristics

Frame: Chromaly (Cr-Mo) steel. Upholstery: Nylon. Wheels: Nylon/fiber rims, pneumatic or hard rubber tires. Casters: High-impact polypropylene, thermoplastic elastomer tires. Dimensions: 31" length, 25-26" width (open), 29-30.5 lbs weight. Capacity: 250 lbs. Manual propulsion via handrims or assistant-pushed. No software or electronic components.

Indications for Use

Indicated for immobile individuals requiring transport due to injury or medical conditions. Operable by an assistant via rear handle bars or by the occupant via handrims if upper torso mobility is present. Maximum weight capacity 250 lbs.

Regulatory Classification

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.

Predicate Devices

• Everest and Jennings Lightning Wheelchair (K930412)

Submission Summary (Full Text)

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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

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## 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.

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## 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.

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## 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<br>(Notch, 23deg C) | ASTM D-256 | KG-CM/CM |
| Tensile Strength at<br>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<br>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<br>(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

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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.

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#### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)