(14 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard powered wheelchair and does not mention any AI or ML capabilities.
No
The device is a powered wheelchair intended to provide mobility, which is an assistive device rather than a therapeutic device that treats or prevents a medical condition.
No
The device is described as a "power chair" and "powered wheelchair" intended to provide mobility, not to diagnose any condition.
No
The device description clearly outlines a physical, battery-operated powered wheelchair with motors, wheels, a frame, seat, and a controller with a joystick. This is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to individuals with limited mobility, specifically those who can operate a powered wheelchair. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a powered wheelchair with components like motors, batteries, wheels, and a controller. These are all related to providing physical mobility.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through laboratory tests, or providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The Mini Power Chair MN 5000 is a medical device, but it falls under the category of a mobility aid, not an IVD.
N/A
Intended Use / Indications for Use
The Mini Power Chair MN 5000 is intended to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair. The Mini Power Chair MN 5000 provides an optional means of mobility for physically challenged people.
Product codes
ITI
Device Description
The Mini Power Chair MN 5000 is an indoor/outdoor powered wheelchair that is battery operated. It has four wheels and anti-tip. The design of this wheelchair is basically similar to other power chairs that are already on the market. But the MN 5000 is kind of a new class of lightweight power chair. By providing a power chair that breaks down into four manageable components(seat, battery pack, front frame and rear frame), a user can have a more practical alternative when traveling long distances by auto, bus, train, etc. MN 5000 achieves it by using a lightweight tubular design with quick disapart front and rear frames, easily detachable seat and a quick release battery pack system.
MN 5000 has two motors, an off-board battery charger, a fully programmable controller, and a removable battery pack.
The wheelchair has a sturdy base which contains the motors, provides space for the battery box and supports the padded seat. The breaking system is automatic and clectric. The seat has adjustable armrest and footrest. There is a controller with a joystick that attaches to either armrest and allows the rider to control the movement of the power chair. The Drive wheels (rear wheels) are 8" in diameter and the Caster wheels (from wheels) are 6".
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Following FDA's recommended list of testing in the classification database for Powered wheelchairs, the device has been tested to appropriate ISO & ANSI/RESNA standards. Among other things, tests were conducted to evaluate the static and dynamic stability of the wheelchair, its energy requirements, performance of breaks etc. It passes EMC requirements. Flame retardant tests of the upholstery materials also meet requirements.
Clinical Testing:
Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
0
Exhibit E
510(k) Summary
Administrative Information and Device Identification
SEP - 8 2006
| Name and address of the manufacturer and
sponsor of the 510(k) submission: | Line Ind. (Shanghai) Co., Ltd.
168 XinSheng Road, ZhaoTun Zhen
QingPu Qu, Shanghai -- 201700, China |
|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Official contact person for all correspondence: | Brendan Lee
Phone: 86-21-59228688-1700
Fax: 86-21-59228922
E-mail: brendanlee@care-line.co.kr |
| Date Prepared: | July 19, 2006 |
| Device Name: | Mini Power Chair MN 5000 |
| Generic name of the device: | Powered wheelchair |
| Classification of new device: | Class II |
| Classification Panel: | Physical Medicine |
| Product Code and CFR Regulation Number: | ITI and 21 CFR 890.3860 |
| Predicate Device Name and 510(k) Number: | PHFW-10; K022539 |
I
1
Description of Device:
The Mini Power Chair MN 5000 is an indoor/outdoor powered wheelchair that is battery operated. It has four wheels and anti-tip. The design of this wheelchair is basically similar to other power chairs that are already on the market. But the MN 5000 is kind of a new class of lightweight power chair. By providing a power chair that breaks down into four manageable components(seat, battery pack, front frame and rear frame), a user can have a more practical alternative when traveling long distances by auto, bus, train, etc. MN 5000 achieves it by using a lightweight tubular design with quick disapart front and rear frames, easily detachable seat and a quick release battery pack system.
MN 5000 has two motors, an off-board battery charger, a fully programmable controller, and a removable battery pack.
The wheelchair has a sturdy base which contains the motors, provides space for the battery box and supports the padded seat. The breaking system is automatic and clectric. The seat has adjustable armrest and footrest. There is a controller with a joystick that attaches to either armrest and allows the rider to control the movement of the power chair. The Drive wheels (rear wheels) are 8" in diameter and the Caster wheels (from wheels) are 6".
Comparison of Device Technological Characteristics to Predicate Device:
The device has similar technological characteristics as the predicate device. They all use steel in their frames and components, and standard foams and covers for the slings, backs and cushions. Microprocessors are typically used with a programmable controller, and the end-user controls the chair by using a joystick or other equivalent command mode. Motors use 24volt DC rechargeable batteries for an energy source. The operating speeds, maneuverability, power modules, hand controls, seat types, drive wheels, and climbing ability are substantially equivalent and are recommended for indoor and moderate outdoor use. The standard accessories and components are common to all power wheel chair devices.
The Mini Power Chair MN 5000 uses the VR2 controller while the predicate uses VST. Both controllers are from the same manufacturer and have basically the same functionality. The changes are mainly related to size, ergonomics and enhancement of existing features. Verification and validation testing confirms that a wheelchair fitted with VR2 performs as intended.
A shorter range of operation, along with a more portable and light weight design allows the Mini Power Chair MN 5000 to use less powerful batteries when compared to the predicate device. Detailed testing has confirmed that these changes do not affect the performance or safety of the wheelchair.
2
2
Intended Use:
The Mini Power Chair MN 5000 is intended to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair. The Mini Power Chair MN 5000 provides an optional means of mobility for physically challenged people.
Non-Clinical Testing:
Following FDA's recommended list of testing in the classification database for Powered wheelchairs, the device has been tested to appropriate ISO & ANSI/RESNA standards. Among other things, tests were conducted to evaluate the static and dynamic stability of the wheelchair, its energy requirements, performance of breaks etc. It passes EMC requirements. Flame retardant tests of the upholstery materials also meet requirements.
Clinical Testing:
Not applicable
Conclusion:
The MN 5000 is substantially equivalent to the predicate device listed in this Summary and the device, as changed, does not raise any new issues of safety and effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2006
Line Ind. (Shanghai) Co., Ltd % Intertek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K062483
Trade/Device Name: Mini Power Chair MN 5000 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: August 24, 2006 · Received: August 25, 2006
Dear Mr. Lehtonen:
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, Drug, 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.
4
Page 2 - Mr. Daniel W. Lehtonen
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Brichm
Mark N. Mel Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
Page .. ()[
510(k) Number (if known): Not Assigned as of this time
Device Name: MINI POWER CHAIR MN 5000
Indications for Use:
The Mini Power Chair MN 5000 is intended to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchain. The Mini Power Chair MN 5000 provides an optional means of mobility for mysically chill vendl people.
Prescription Use (Per 21 CFR 801 Subpart D)
ાર
Over-The Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchholz for MXM
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
May 10, 2006 Line Ind.(Shanghai) Co., Ltd.
/
510(k) Number K062483