BREEZY SERIES

K974820 · Sunrise Medical, Inc. · IOR · Jan 27, 1998 · Physical Medicine

Device Facts

• Record ID: K974820
• Device Name: BREEZY SERIES
• Applicant: Sunrise Medical, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Jan 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

Quickie manual wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages such as: Arthritis, Amputee, Paraplegic, Cerebral Palsy, Hemiplegic, Tetraplegic, Quadriplegic, Spina Bifida, Head Injury or Trauma, Muscular Dystrophy, Multiple Sclerosis, Polio, Geriatric conditions And other immobilizeing or debilitating condition. A wheelchair with Bus Transport Option may be used for motor vehicle transportation, with the use of wheelchair tie down and occupant restraint system (WTORS) that meet the requirements of SAE J2249

Device Story

Breezy series are lightweight manual wheelchairs providing mobility for physically challenged users. Devices consist of seat frame, backrest, cushion, footrest, and casters; accessories include armrests, positioning belts, oxygen tank holders, and IV poles. Key update is addition of reclining back model. Chairs are configured to customer orders based on user needs/capabilities; dimensions (width, depth, back height) are adjustable. Used in indoor/outdoor environments with firm surfaces. Healthcare professionals and users determine appropriate configuration. Reconfiguration possible as user needs evolve. Benefits include improved mobility and maneuverability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual wheelchair; lightweight frame construction. Adjustable dimensions (width, depth, back height). Components include backrest, seat frame, cushion, footrest, casters. Accessories include positioning belts, IV poles, oxygen tank holders. No electronic components or software.

Indications for Use

Indicated for physically challenged individuals of all ages with temporary or permanent mobility-limiting conditions, including arthritis, amputation, paraplegia, cerebral palsy, hemiplegia, tetraplegia, quadriplegia, spina bifida, head injury/trauma, muscular dystrophy, multiple sclerosis, polio, or geriatric conditions.

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

• Sunrise Invacare's Everest & Jennings
• Breezy Family 9000 Universal
• EZ LITE

Submission Summary (Full Text)

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510k Notification - Breezy 510 Recliner and Model Number Updates

#### 13.0 510(k) SUMMARY OF SAFETY AND EFFICACY

Rebecca Andersen Submitter: Date: December 18, 1997

R974820

JAN 27 1998

Name(s) of the device(s):

## Breezy Series

Identification of predicate device(s):

Sunrise Invacare's Everest & Jennings' Everest and Jennings

Breezy Family 9000 Universal EZ LITE

# Description of the device:

The Breezy series wheelchairs are light weight manual chairs. These chairs are intended to provide mobility based on an individual users' needs and capabilities. They are available in a range of sizes (dimensions) to allow fit to a particular user, and is adjustable in various ways, including: The key change covered by this submission is the addition of a reclining back model to the Breezy product line.

Chairs are configured to customer orders when sold. Configuration to order allows flexibility. Features such as width, depth, and back height are specified. Specific configuration includes chair accessories and desired safety features. Any combination of features from the approved matrix may be configured to create the chair features needed by a given rider It is the rider and the health care professional that determine the appropriate configuration for the users needs. As the individuals condition or size change, other components or accessories may be ordered and the chair reconfigured to meet the evolving needs of its user.

Breezy wheelchairs with or without the reclining back option, consists of typical components found on most wheelchairs, such as backrest, seat frame, cushion, footrest and casters. Accessories include items such as armrests, positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc.

Many of these components may become available in a range of sizes, shapes, angles, forms, materials or coverings. These variations allow the chairs to be configured to meet the specific desires and needs of the user.

The chairs have excellent performance indoors and are very good outdoors over surfaces that are firm ad free of large obstacles and long steep inclines. That makes them an ideal maneuverable, light weight "Get out there chair".

Warnings, cautions and contraindications are detailed in the users manual.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 1998

Ms. Rebecca Andersen · Vice President, Quality and Requlatory Affairs Sunrise Medical 7477 East Dry Creek Parkway Longmont, Colorado 80503

Re: K974820 Breezy Series Regulatory Class: I Product Code: IOR Dated: December 16, 1997 Received: December 23, 1997

Dear Ms. Andersen:

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. 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 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 requlations.

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#### Page 2 - Ms. Rebecca Andersen

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 Other general premarket notification" (21 CFR 807.97). 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,

Acotello

CelNa 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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# 12.2 Indications for Use

### Intended use:

Quickie manual wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages such as:

| Arthritis |
|----------------|
| Amputee |
| Paraplegic |
| Cerebral Palsy |
| Hemiplegic |

Tetraplegic Quadriplegic Spina Bifida Head Injury or Trauma Muscular Dystrophy

Multiple Sclerosis Polio Geriatric conditions And other immobilizeing or debilitating condition

A wheelchair with Bus Transport Option may be used for motor vehicle transportation, with the use of wheelchair tie down and occupant restraint system (WTORS) that meet the requirements of SAE J2249

510(k) number: Not assigned as of this time

Device name: Breezy Series

Which today consist of : Breezy 500 Breezy 510 Breezy 510 Recliner Breezy 600

Concurrence of CDRH, Office of Device Evaluation (ODE)

[ Prescription use (per 21 CFR801.109)

Over-the-counter use

coop
(D

· Restorative Devic 5 Tulk) Number

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three waves emanating from its body, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 1998

Mr. Zhou Shun Kao Wenzhou Hindar Optical Co., Ltd. No. 46-5 Liming Mid Road Wenzhou City, China

Re: K974861 Trade Name: Non-prescription Sunglasses Regulatory Class: I Product Code: 86 HQY Dated: December 17, 1997 Received: December 29, 1997

Dear Mr. Kao:

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 requirements, 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.

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Page 2 - Mr. Zhou Shun Kao

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 its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of

510(k) Number (if known): K974861

Device Name: Sunglasses

Indications For Use:

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Am Williams
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K974861

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use XXX

(Optional Format 1-2-96)