← Product Code [IOR](/productcode/IOR) · K060582 # INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR (K060582) _Invacare Corporation · IOR · Mar 16, 2006 · Physical Medicine · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K060582 ## Device Facts - **Applicant:** Invacare Corporation - **Product Code:** [IOR](/productcode/IOR.md) - **Decision Date:** Mar 16, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 890.3850 - **Device Class:** Class 1 - **Review Panel:** Physical Medicine ## Indications for Use The intended use of the Invacare Topaz Bariatric Manual Wheelchair is to provide mobility to persons that may be restricted to a sitting position. ## Device Story The Invacare Topaz is a manually operated, user-propelled mechanical wheelchair designed for bariatric patients weighing up to 1000 lbs. It consists of a welded steel frame, large rear wheels with hand rims, and front pivoting casters. The device is a modification of the Model 9000 Bariatric Wheelchair, featuring a reinforced frame design to accommodate higher weight capacities. Structural reinforcements include two extra gussets on the frontal tube, thicker gussets on the rear upright and head tube, reinforced armrests, and a stronger front caster tire. The wheelchair is used in various settings to provide mobility to individuals restricted to a sitting position. It is operated by the user or an assistant. The device provides physical mobility, enabling independent or assisted movement for the patient. ## Clinical Evidence Bench testing only. The device was tested in accordance with ISO 7176, parts 1 and 8, to verify the structural integrity of the reinforced frame design under the increased 1000 lb weight capacity. Results demonstrated that all predetermined acceptance criteria were met. ## Technological Characteristics Mechanical wheelchair; welded steel frame construction (1" O.D. round tubing, 1/8" wall thickness); folding/non-rigid design; manual propulsion via hand rims; front pivoting casters. Dimensions: seat width 28"-30", seat-to-floor height 17.5"-19.5". Complies with ISO 7176 parts 1 and 8. ## Regulatory 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 - Invacare Model 9000 Bariatric Wheelchair ([K002317](/device/K002317.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the Invacare logo. The logo is in black and white and features the word "INVACARE" in a bold, sans-serif font. The word is placed inside of a black oval shape. There is a small registered trademark symbol to the right of the word. ## SPECIAL 510(K) SUMMARY FOR THE MODIFICATION TO INVACARE'S MODEL 9000 BARIATRIC MANUAL WHEELCHAIR (TOPAZ) This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92 The assigned 510(k) number is K060582 Date: March 6, 2006 Submitted by: Invacare Corporation One Invacare Way Elyria, Ohio 44035-4190 Telephone: 440-329-6356 Fax: 440-326-3607 Contact Person: Mr. Carroll Martin Trade Name: Topaz Common Name: Manual Wheelchair Classification Name: Wheelchair, mechanical per 21 CFR Section 890.3850 Legally Marketed Predicate Device(s): Invacare Model 9000 Bariatric Wheelchair K002317, August 25, 2000 Device Description: The Invacare Model 9000 Bariatric Manual Wheelchair (Topaz) is a manually operated, user propelled mechanical wheelchair. Its intended function and use is to provide mobility to persons limited to a sitting position. The wheelchair consists primarily of a steel frame, large rear wheels with hand rims for propelling the wheelchair, and smaller front pivoting casters for steering and turning. It is a folding, or non-rigid type of wheelchair that is designed for use by patients weighing up to 1000 lbs. The frame is constructed of round, steel tubing that is welded. The tubing is 1" outside diameter (O.D.) with a wall thickness of 1/8". The seat width ranges from a minimum of 28" wide to a maximum of 30" wide and seat to floor height ranges from 17½" to 19½". The modification to this device consists of a frame with a reinforced design to withstand the higher weight capacity of 1000 lbs. In particular, two extra gussets have been added to the frontal tube and thicker gussets have been added to the rear upright and head tube. Also, the armrests have been reinforced and a stronger tire is used on the front caster. > Invacare Special 510(k) Page 9 re Way P.O. Box 4028 Elyria. OH 44036-2125 USA 440-329-6000 Fax: 440-365-4558 www.invacare.com {1}------------------------------------------------ Image /page/1/Picture/0 description: The image is a logo for Invacare. The logo is an oval shape with the word "INVACARE" in white letters on a black background. The logo is simple and easy to recognize. The font is sans-serif and bold. Intended Use: The intended use of the modified Invacare Topaz Bariatric Manual Wheelchair (Topaz) is to provide mobility to persons that may be restricted to a sitting position. Substantial Equivalence: The modified Topaz is substantially equivalent to the Invacare Substantial Equivateric Manual Wheelchair, cleared on August 25, 2000 under 510(K) Accession Number K002317. It is a modification of the Model 9000 Bariatric Manual Accessfori Namber 1200251771 consist of a frame with a reinforced design to withstand wheeleman. The modifications conbis. In particular, two extra gussets have been added the frontal tube and thicker gussets have been added to the rear upright and head tube. to the froman tabe and therer gaster. Also, the armrests have been reinforced and a stronger tire is used on the front caster. The intended use of providing mobility to persons restricted to a sitting position and the functionality of the device, i.e. manual operation, remain the same. The major difference functionally of the devices and the subject of this Special 510(k) is that the Invacare Model 9000 Bariatric Manual Wheelchair has a weight capacity of 700 pounds. This 9000 Dariante Manual Whosehull is weight capacity of the wheelchair to increase to 1000 pounds. Performance Testing: The performance testing conducted as a result of the modifications I chomiance Testing. The performal Wheelchair (Topaz), as required by the to the mvacare Model 7000 Baradith i results demonstrated that the predetermined acceptance criteria were met. Performance Standards: Although no performance standards have been established under Performance Stailuards: Annough no percentiality of mechanical wheelchairs, Invacarc Section 514 of the Food, Drug and Cosmetic Act for mechanical wheelcharie Section 314 of the Food, Drug and Cosmode Ford Color Bariatric Manual Wheelchair (Topaz) in accordance with ISO 7176, parts 1 and 8. > Invacare Special 510(k) Page TO ## VACARE CORPORATI {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 6 2006 Invacare Corporation c/o Mr. Carroll Martin One Invacare Way Elyria, Ohio 44035-4190 Re: K060582 Trade/Device Name: Invacare Topaz Bariatric Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: March 6, 2006 Received: March 8, 2006 Dear Mr. Martin: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Drue, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Mr. Carroll Martin This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Herbert Spencer 05 Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): _ Device Name: Invacare Topaz Bariatric Manual Wheelchair Indications for Use: The intended use of the Invacare Topaz Bariatic Manual Wheelchair is to provide mobility to persons that may be restricted to a sitting position. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) X (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IT NEEDED) Concurrence of CDRH, Office af Device Evaluation (ODE) Herbert Lemmer Provision Sign-O Division of General, Restorative, ond Neurological Devices **510(k) Number** K060582 Page 1 of --- **Source:** [https://fda-staging.innolitics.com/device/K060582](https://fda-staging.innolitics.com/device/K060582) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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