MANUAL WHEELCHAIR

K982607 · G. Hirsch and Co., Inc. · IOR · Aug 31, 1998 · Physical Medicine

Device Facts

• Record ID: K982607
• Device Name: MANUAL WHEELCHAIR
• Applicant: G. Hirsch and Co., Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Aug 31, 1998
• 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 folding chromed steel frame with cross braces, slung fabric seat 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. Operated by patient or attendant in various settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Chromed steel frame, slung fabric seat/back, manual propulsion via handrims or attendant push handles, lever-style wheel locks. Dimensions: 14"-22" width, 20" seat height, 24" rear wheels, 8" front casters. Weight: 42 lbs. Weight limit: 250 lbs.

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)
• Tracer Series Manual Wheelchairs (K945175)
• Bantex Brand Wheelchairs (K35398)
• Universal Wheelchair (K930411)
• Invacare Tracer Series wheelchairs (K935398)

Submission Summary (Full Text)

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1 CI S R D FAITH CALL F τ

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AUG 3 1 1998

KG82607

## 510(k) SUMMARY

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

(1) Submitted by: G. Hirsch and Company, Inc. 1815 Rollins Road Burlingame, CA 94010-2204 Phone [phone] Contact: Garv Hirsch Prepared 07/24/98

- (2) Proprietary Name: Manual Wheelchair Common Name: Manual Wheelchair Classification Name: Wheelchair, Mechanical
(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 Manual Wheelchairs, K35398 Bantex Brand Wheelchairs, K915262 Universal Wheelchair, K930411

(4) The device consists of a folding chromed steel frame with cross braces, slung fabric seat 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 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.

| | Our submitted wheelchair | Invacare Tracer Wheelchair (510(k)#K935398) |
|------------------|--------------------------|---------------------------------------------|
| 1. Seat Ht. | 20" | 20" |
| 2. Widths | 14" – 22" | 14" - 20" |
| 3. Rear Wheels | 24" | 24" |
| 4. Front Casters | 8" | 8" |
| 3. Product Wt. | 42 lbs. | 44 lbs. |
| 4. 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 1998

Mr. Gary Hirsch President G. Hirsch and Company, Inc. 1815 Rollins Road 94010 Burlingame, California

Re: K982607 Manual Wheelchair Trade Name: Regulatory Class: I Product Code: IOR Dated: July 24, 1998 Received: July 27, 1998

Dear Mr. Hirsch:

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 Requlations, Title 21, Parts 800 to 895. ಡಿ 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 requlation 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.

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## Page 2 - Mr. Gary Hirsch

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 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 1 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:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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For transportation of disabled persons.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of General Restorative Devices 16982607 510(k) Number.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use
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