(147 days)
No
The description focuses on the mechanical and electrical components of a powered wheelchair and does not mention any AI or ML capabilities.
No
The device is a powered wheelchair designed for mobility, not to treat or diagnose a medical condition.
No
The device description indicates that the Permobil powered wheelchair is designed to provide mobility for individuals, which is a functional aid, not a diagnostic tool used to identify or analyze medical conditions.
No
The device description clearly outlines a physical, hardware-based powered wheelchair with motors, batteries, a frame, wheels, and a controller. It is not solely software.
Based on the provided information, the Permobil powered wheelchair 1280 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide mobility to persons restricted to a sitting position. This is a mechanical function for physical assistance, not a diagnostic test performed on biological samples.
- Device Description: The description details a powered wheelchair with components like a base, wheels, batteries, motor, and controller. These are all related to providing mobility and control, not to analyzing biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on biological analysis.
Therefore, the Permobil powered wheelchair 1280 falls under the category of a medical device for mobility assistance, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of Permobil powered wheelchair 1280 is to provide indoor and outdoor mobility to persons restricted to a sitting position.
Product codes
ITI
Device Description
The Permobil powered wheelchair 1280 is front wheel driven, battery powered, motor driven and is controlled by the Penny & Giles compact powered wheelchair controller Pilot +. The joystick is integrated in the controller. The wheelchair is powered by two 12V 73 Ah batteries. Theoretical driving range on the fully charged batteries is 35 km. The wheelchair consists of two basic sub-sections. These are the base with motor controller and the body supporting system. In this submission, only the design changes made to base is included. The base is of welded steel construction and includes the base frame, front drive wheels with drive unit (motor/gear/brakes), batteries and pivoting rear casters. The motor controller is mounted to the left or right armrest, depending on user needs. The motor controller, including the joystick, is housed in a pressure die cast aluminum enclosure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Permobil Chairman L/CS 8 (K960951), G-424 power wheelchair (K983677)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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- ブ
OCT 8 1999
1252
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
K991658
PERMOBIL POWERED WHEELCHAIR 1280
| Submitter | Permobil AB
Box 120
S-861 23 Timrå
Sweden |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone
Fax | +46 60 59 59 00
+46 60 57 52 50 |
| Contact person
E-mail address | Bengt Persson
bengt.persson@permobil.se |
| Date Prepared | May 10 1999 |
| Device name | Powered wheelchair 1280 |
| Classification name | Powered wheelchair |
| Identification of predicate devices | Permobil Chairman L/CS 8 (K960951)
G-424 power wheelchair (K983677) |
| Intended use | The intended use of Permobil powered wheelchair 1280 is to provide indoor and
outdoor mobility to persons restricted to a sitting position. |
| Description of the device | The Permobil powered wheelchair 1280 is front wheel driven, battery powered,
motor driven and is controlled by the Penny & Giles compact powered wheelchair
controller Pilot +. The joystick is integrated in the controller.
The wheelchair is powered by two 12V 73 Ah batteries.
Theoretical driving range on the fully charged batteries is 35 km.
The wheelchair consists of two basic sub-sections. These are the base with motor
controller and the body supporting system. In this submission, only the design
changes made to base is included. The base is of welded steel construction and
includes the base frame, front drive wheels with drive unit (motor/gear/brakes),
batteries and pivoting rear casters. The motor controller is mounted to the left or
right armrest, depending on user needs.
The motor controller, including the joystick, is housed in a pressure die cast
aluminum enclosure. |
| Substantial equivalence
The Permobil powered wheelchair 1280 is substantial equivalent with respect to,
intended use, energy source and materials, because those are identical to the
predicate device(s). | |
The key changes are frame suspension and use of the Pilot + controller from Penny & Giles instead of the PG8 controller from Penny & Giles.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
PERMOBIL POWERED WHEELCHAIR 1280
Jos
1699/1658
Safety and effectiveness
The Permobil powered wheelchair 1280 has in substantials the same technological characteristics and the same safety and effectiveness as the predicate device(s) and the minor design changes declared in this submission do not raise new questions of safety and effectiveness.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 8 1999
Mr. Bengt Persson Quality Manager Permobil A.B. Engelbrekts Vag 101 S-191 62 Sollentuna, Sweden
Re: K991658
Trade Name: Permobil Powered Wheelchair 1280 Regulatory Class: II Product Code: ITI Dated: July 7, 1999 Received: July 12, 1999
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.
3
Page 2 - Mr. Bengt Persson
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 (301) 594-4595. 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 vours.
Mark N Milhusan
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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PERMOBIL POWERED WHEELCHAIR 1280
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
Not decided at writing of this submission Working name, also use in this submission, 1280
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use (per 21 CFR 801.109) □
or
Over the counter use of
Mark M. Mellikerson
(Division Sign Off)
(Division Sign-Off) Division of Ggeneral Restorative Devices
510(k) number
(k) number K99/65Y