(437 days)
The intended use of TRAX is to provide indoor and outdoor mobility to persons restricted to a sitting position.
Powered wheelchair, battery-operated device with wheels that is intended for medical purposes to provide indoor and outdoor mobility to persons restricted to a sitting position. Class II. The indoor use is depending of available space.
The Permobil powered wheelchair TRAX is rear wheel driven, battery powered, motor driven and is controlled by the Permobil wheelchair controller SAFEGATE. The user interface is a joystick manufactured by Sakai for proportional control of the speed and the steering.
The wheelchair is powered by two 12V 97 Ah gel batteries.
Theoretical driving range on the fully charged batteries is 30 - 50 km depending of the terrain the chair is driven on.
The wheelchair consists of the following basic sub-sections:
- · Base with two direct-drive units with integrated parking brakes, two 10"x3" rear wheels, suspension with stabilizer and two 12V 97Ah batteries.
- Extendable and pivoted front, length adjustable 0-200 mm (0-8"), teleflex . wire steering, suspension and two 8"x2,5" front wheels.
- SAFEGATE TRAX Power electronics. .
- · Seating system.
The base is of welded steel construction with laser cut sheet details. The direct-drive units consist of two 12V DC permanent magnet motors with gears and integrated parking brakes.
I am sorry, but based on the provided document, the requested information regarding acceptance criteria and a study proving the device meets those criteria is not available.
The document is a 510(k) Summary of Safety and Effectiveness for the Permobil Powered Wheelchair TRAX. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting specific performance acceptance criteria and a study to prove they are met for the TRAX device itself.
Here's what the document does include:
- Intended Use: "to provide indoor and outdoor mobility to persons restricted to a sitting position."
- Description of the Device: Details on its components (base, drive units, batteries, steering, seating system).
- Substantial Equivalence Claim: States that the TRAX is substantially equivalent to predicate devices (Max90 (K870224) and Exterior (K870225)) with respect to intended use, energy source, and materials.
- Safety and Effectiveness Claim: States that the TRAX has "in substantials the same technological characteristics and the same safety and effectiveness as the predicate device(s) and the design changes declared in this submission do not raise new questions of safety and effectiveness."
Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The document's purpose is to argue for substantial equivalence to already approved devices, implicitly relying on the predicate devices having met necessary performance and safety criteria. It does not detail specific acceptance criteria for the TRAX and then a study showing how the TRAX met those specific criteria.
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K99 3906
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
PERMOBIL POWERED WHEELCHAIR TRAX
8 2000
| Submitter | Permobil ABBox 120S-861 23 TimråSweden | DEC 1 |
|---|---|---|
| Phone | +46 60 59 59 00 | |
| Fax | +46 60 57 52 50 | |
| Contact person | Bengt Persson | |
| E-mail address | bengt.persson@permobil.se | |
| Date Prepared | September 30 1999 | |
| Device name | TRAX | |
| Classification name | Powered wheelchair |
ldentification of predicate devices Max90 (K870224) Exterior (K870225)
Intended use
The intended use of TRAX is to provide indoor and outdoor mobility to persons restricted to a sitting position.
Description of the device
The Permobil powered wheelchair TRAX is rear wheel driven, battery powered, motor driven and is controlled by the Permobil wheelchair controller SAFEGATE. The user interface is a joystick manufactured by Sakai for proportional control of the speed and the steering.
The wheelchair is powered by two 12V 97 Ah gel batteries.
Theoretical driving range on the fully charged batteries is 30 - 50 km depending of the terrain the chair is driven on.
The wheelchair consists of the following basic sub-sections:
- · Base with two direct-drive units with integrated parking brakes, two 10"x3" rear wheels, suspension with stabilizer and two 12V 97Ah batteries.
- Extendable and pivoted front, length adjustable 0-200 mm (0-8"), teleflex . wire steering, suspension and two 8"x2,5" front wheels.
- SAFEGATE TRAX Power electronics. .
- · Seating system.
The base is of welded steel construction with laser cut sheet details. The direct-drive units consist of two 12V DC permanent magnet motors with gears and integrated parking brakes.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
PERMOBIL POWERED WHEELCHAIR TRAX
Substantial equivalence
The Permobil powered wheelchair TRAX is substantial equivalent with respect to, intended use, energy source and materials, because those are identical to the predicate device(s).
Safety and effectiveness
The Permobil powered wheelchair ITRAX has in substantials the same technological characteristics and the same safety and effectiveness as the predicate device(s) and the design changes declared in this submission do not raise new questions of safety and effectiveness.
Indication for Use
The intended use is to provide indoor and outdoor mobility to persons restricted to a sitting position.
510(k) number
Not assigned at the writing of this submission
Device name
TRAX
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use (per 21 CFR 801.109) []
or
Over the counter use
(Division Sign-Off) Division of Ggeneral Restorative Devices
510(k) number
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes. The symbol is rendered in black, and the text is also in black against a white background.
Public Health Service
DEC 1 8 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bengt Persson Quality Manager Permobil AB Engelbrekts vag 101 S-191 62 Sollentuna Sweden
Re: K993406
Trade Name: Trax, Powered Wheelchair, Model 308686-00-0 Regulatory Class: II Product Code: ITI Dated: November 22, 2000 Received: November 22, 2000
Dear Mr. Persson:
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. Bengt Persson
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark N Millikan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) notification K993406
FDA's request for additional information dated, January 6, 2000.
Enclosure D
510(k) Number (if known):
K9930406
Permobil TRAX
Device Name:
Indication For Use:
Powered wheelchair, battery-operated device with wheels that is intended for medical purposes to provide indoor and outdoor mobility to persons restricted to a sitting position. Class II. The indoor use is depending of available space.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Mark N. Mulkison
(Division Sign-Off)
Division of General Restorative Devices
K993906
510(k) Number _
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).