(42 days)
Not Found
No
The summary describes a standard powered wheelchair with a focus on its portability and battery operation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The document states its intended use is to "provide mobility to disabled or elderly persons limited to a seated position." While it aids mobility, it does not treat, diagnose, or prevent any medical condition, which are characteristic functions of a therapeutic device.
No
Explanation: The device is described as a powered wheelchair for transportation and mobility, not for diagnosing medical conditions.
No
The device description clearly states it is a "powered wheelchair" which is a physical, hardware-based device with motors and a battery pack. It is not solely software.
No, the Zip'r PC powered wheelchair is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Zip'r PC Intended Use: The intended use of the Zip'r PC is clearly stated as providing mobility to disabled or elderly persons. It is a transportation device, not a device that analyzes biological samples.
- Device Description: The description focuses on the mechanical and electrical aspects of the wheelchair, not on any diagnostic capabilities.
The information provided confirms that this device is a mobility aid, not an IVD.
N/A
Intended Use / Indications for Use
Zip'r PC powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.
The Zip'r PC powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Product codes
ITI
Device Description
The Zip'r PC powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. By providing a powered wheelchair that breaks down into two manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
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)
Not Found
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
SEP 2 1 2007
Global FabTech Wheelchair (Shanghai) Co., Ltd.
No. 318, TianFu Rd., Jiuting Songjiang, Shanghai, 201615, China TEL: +86-21- 6763-2308 FAX: +86-21- 6763-2309
510(k) Summary
Device
Trade name: Zip'r PC powered wheelchair Common name: Powered wheelchair Classification name: Powered wheelchair Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3860 Product Code: ITI Classification: Class II
Predicate devices
CWD01 (K062888) / EMG Technology Co. Ltd.
Intend use of device
Zip'r PC powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.
Device description:
The Zip'r PC powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. By providing a powered wheelchair that breaks down into two manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
Substantial equivalence:
The Zip'r PC powered wheelchair is substantially equivalent to the CWD01 (K062888) manufactured by EMG Technology Co. Ltd..
There are minor differences in performance specifications of the powered wheelchairs, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, Global FabTech Wheelchair (Shanghai) Co., Ltd. believes that the Zip'r PC powered wheelchair is substantially equivalent to legally marketed devices currently in commercial distribution.
1
l FabTech Wheelchair (Shanghai) Co.,
18, TianFu Rd., Jiuting Songjiang, Shanghai, 201615, China
TEL: +86-21- 6763-2308 FAX: +86-21- 6763-2309
intended for medical purposes to provide
ility to persons restricted to a sitting posi CWD01 (K0628 ad-Acid 12V×35AH×2 'U foaming tire × 2 60W x DC24V × 2Pc numatic tire × 2 4V 5A, off-bo 6 kg ( 300 lb 30 mm (44.5 00 mm ( 35.4 50 mm ( 25.6 Dynamic Shar direct drive ﺔ ﺍﻟ ealed transaxle bled or elderly persons limited to a seated pos notor driven, indoor and outdoor transport 5 AMP (Automatic Type) off-b s with the intended use to provide mob 12V × 33AH × 2PG Solid tire × 2 P Solid tire × 2 Po Zip'r PC ad-Acid 6 kg (35 lbs)
OC 24V, 320 W, 2 Pcs 6 kg (300 lbs 020 mm (40) 30 mm (24" 90 mm (39" 70 mm (23 620mm (21' 609mm (24 PG VRI at overall weigl t overall heigl at overall dept t overall widt iximum loadi Rear wheel driv verall heigh verall lengt verall widt tended use lotor outpu Front whee Rear whee ontrolle Charge Batter
ubstantial equivalence comparison of the Zip'r PC and CW
7-2
2
| Continuous) | The substantial equivalence comparison of the Zip'r PC and CWD01 | Zip'r PC | CWD01 (K062888) |
|---|---|---|---|
| Armrest | Fixed | Removable | |
| Break system | Intelligent regenerative electromagnetic brake | ||
| Braking distance | Forward: 1.4 m(56") at max speed | ||
| Net weight w | |||
| battery | 68 kg (150 lbs) | 83.5kg (183.7 lbs) | |
| Slope grade ability | 8 degree | 12 degree | |
| Per-charge distance | Up to 40 km (25 miles) | 40 km (24 miles) | |
| Maximum speed | Up to 6.4 km/hr (4 mph), variable | 5 km/h (3.2 mph) | |
| Turning radius | 0.51 m (20") | ||
| Maximum curb | |||
| height | 25 mm (1") | ||
| Suspension | Front: No, Rear: No | Cross brace | |
| Horn | Yes | Yes | |
| Anti-tip wheels | Yes | Yes |
Global FabTech Wheelchair (Shanghai) Co., Ltd.
7-3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
L ISEF 2 1 7007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Global FabTech Wheelchair (Shanghai) Co., Ltd. % Mr. Edward Dong No. 318, TianFu Rd. Jiuting Songjiang Shanghai, 201615, China
K072224 Trade/Device Name: Zip'r PC Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: August 7, 2007 Received: August 10, 2007
Dear Mr. Dong:
Re:
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. Edward Dong
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
- Device descriptive information
3.1 Statement of indication for use
Statement of Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Zip'r PC
Indications for Use:
The Zip'r PC powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Over-The-Counter Use _ X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR (Part 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K672224
(Posted November 13, 2003)