SIGMA MANUAL WHEELCHAIR

K993963 · Sigma Distribution & Supply, Inc. · IOR · Jan 13, 2000 · Physical Medicine

Device Facts

• Record ID: K993963
• Device Name: SIGMA MANUAL WHEELCHAIR
• Applicant: Sigma Distribution & Supply, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Jan 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

For transportation of disabled persons.

Device Story

Manual wheelchair for transportation of disabled persons. Features chromed steel frame with cross bars, slung fabric seat and back, fixed or removable armrests, and fixed or removable foot/legrests. Includes front caster wheels for steering, rear push handles for attendant-assisted propulsion, and rear drive wheels with handrims for self-propulsion. Equipped with lever-style wheel locks. Operated by patient or attendant in clinical or home settings.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and comparative analysis of design specifications against predicate devices.

Technological Characteristics

Chromed steel frame; slung fabric seat/back meeting NFPA 701-89 flame resistance standards; manual propulsion via handrims or attendant push handles; lever-style wheel locks; 20" seat height; 14"-22" width range; 24" rear wheels; 8" front casters; 250 lb weight capacity.

Indications for Use

Indicated for the transportation of disabled persons.

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

• Mechanical Wheelchair 980.3850 (K945175)
• Tracer Series Wheelchairs (K935398)
• Bantex Brand Wheelchairs (K915262)

Submission Summary (Full Text)

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## JAN 1 3 2000

## 510(k) SUMMARY

#### This is an Initial 510(k) Summary in accordance with 21 CFR 807.92 (a)

- Submitted by: Sigma Distribution & Supply, Inc. (1) 701 West Harvard Street Glendale, CA 91204 Phone [phone] Contact: Arthur Keshishyan Prepared 10/28/1999
- SIGMA MANUAL WHEELCHAIR (2) Propriety Name: Common Name: Manual Wheelchair Classification Name: Manual, wheelchair

(3) Examples of four legally marketed devices of substantial equivalence, together with their 510(k) numbers are as follows:

> Mechanical Wheelchair 980.3850, K945175 Tracer Series Wheelchairs, K35398 Bantex Brand Wheelchairs, K915262

The device consists of a chromed steel frame with cross bars, slung fabric seat (4) and back, fixed or removable armrests, fixed or removable foot/legrests. Front caster wheels for steering, rear push handles for attendant-assisted propulsion, rear drive wheels with handrims for self-propulsion, and lever-style wheel locks.

(5) The wheelchair is to be used for transportation of disabled persons.

(6) The wheelchair exhibits no material differences from the predicate devices listed in number (3) above. Please see the enclosed catalog pages of FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY compared with the dimensions of Invacare Tracer Series wheelchairs (510(k) #K935398) for a comparison of design features, which we believe to be equivalent to our submitted wheelchair. Some items for comparison are listed below. Furhter the fabric of the subited whhelchair mcets the NFPA 701-89 Flame Resistant Textile and Films test.

| | Our Submitted Wheelchair | Invacare Tracer Wheelchair (510(k) #K93539 |
|------------------|--------------------------|--------------------------------------------|
| 1. Seat Ht. | 20" | 20" |
| 2. Widths | 14"-22" | 14"-22" |
| 3. Rear Wheels | 24" | 24" |
| 4. Front Casters | 8" | 8" |
| Product Wt. | 43lbs | 44lbs |
| Weight Limit: | 250 lbs. | 250 lbs. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 1 3 2000

Mr. Arthur Keshishyan Sigma Distribution & Supply, Inc. 701 West Harvard Street Glendale, California 91204

Re: K993963 Trade Name: Sigma Manual Wheelchair Regulatory Class: I Product Codc: IOR Dated: November 8, 1999 Received: November 22, 1999

Dear Mr. Keshishyan:

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.

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Page 2 - Mr. John T. Mogensen

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 [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,

Mark. .1 Mull...

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KG143963 510(k) Number ::K992389-Device Namc: SIGMA MANUAL WHEELCHAIR

Indication For Use:

For transportation of disabled persons.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __

OR

Over the Counter Use

Monk n Milken

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K993963