(28 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of a standard powered wheelchair controlled by hand controls, with no mention of AI or ML capabilities.
No.
The device provides mobility, which is assistive, not therapeutic in the sense of treating a medical condition or restoring function.
No
The device is described as a powered wheelchair intended for mobility, not for diagnosing medical conditions.
No
The device description clearly describes a physical powered wheelchair with a base, wheels, seat, hand controls, and battery charger, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to persons restricted to a seated position. This is a functional purpose related to physical assistance, not diagnostic testing.
- Device Description: The description details a powered wheelchair, which is a mobility aid. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
Therefore, based on the provided text, this device is a mobility aid and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The Middle Wheel Drive Power Chair, CWD01 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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)
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo and contact information for EMG Technology Co., LTD. The logo features a stylized image of a cheetah above the text "ELECTRIC MEDICAL GROUP". The contact information includes the address "No.58, 35rd., Taichung Industrial Park, Taiwan", as well as the telephone number "Tel:886-4-23596033" and fax number "Fax:886-4-23596031".
0CT 2 4 2006
September 23, 2006
66 510(k) SUMMARY "
Submitter's Name: EMG Technology Co., Ltd.
No. 58, 35 Rd., Taichung Industrial Park, Shituen Chiu, 40768, Taiwan, ROC
Date summary prepared:
Device Name:
| Proprietary Name: | Middle Wheel Drive Power Chair, CWD01 |
|---|---|
| Common or Usual Name: | Powered Wheelchair |
| Classification Name: | Powered Wheelchair, Class II, |
| 21 CER 890 3860 |
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Description of the device:
The Middle Wheel Drive Power Chair, CWD01 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison: EPW POWERED WHEELCHAIR GP-201 ( K023148 )
1
Image /page/1/Picture/0 description: The image shows a logo for Electric Medical Group. The logo features the letters EMG in a stylized font, with a panther leaping across the top. The words "ELECTRIC MEDICAL GROUP" are printed below the letters in a smaller font. The logo is black and white.
EMG TECHNOLOGY CO., LTD.
No.58, 35rd., Taichung Industrial Park, Taiwan Tel:886-4-23596033 Fax:886-4-23596031
部品
中国"中国
C.1 SUMMARY TABLE
| ITEMS | SUBJECT DEVICE | PREDICATE DEVICE |
|---|---|---|
| BRAND NAME | EMG, EPW | EMG, EPW |
| MANUFACTURER | EMG Technology | EMG Technology |
| SERIES | Power wheels | Power wheels |
| MODEL NO | CWD01 | GP-201 |
| 510K NO | TBA | K023148 |
| INTENDED USE | SAME | The device is |
| intended for medical | ||
| purposes to provide | ||
| mobility to persons | ||
| restricted to a sitting | ||
| position. | ||
| Frame | SAME | Unfoldable |
| Overall dimension | ||
| Overall length | 90 cm / 35.4" | 38" |
| Overall width | 65 cm / 25.6" | 24" |
| Overall height | 113 cm / 44.5" | 18" from seat |
| Weight limit | 136 kgs / 300 lbs | 350 lbs |
| Maximum speed | 5 km/hr (3.2 mph) | 5.0 mph |
| Electronics | Dynamic Shark controller | Dynamic DL controller |
| Batteries | ||
| Quantity | Two | Two |
| Type | U1, 35Ah gel cell 12VDC | U1, 30Ah gel cell 12VDC |
| Range per charge | 24 miles (40 km) | 22 miles |
| Suspension | SAME | Cross brace |
| ITEMS | SUBJECT DEVICE | PREDICATE DEVICE |
| Rear wheels | 10" PU foaming tire | 10" pneumatic |
| Casters | 6" x 2" pneumatic | 8" x 2" pneumatic |
| Footplates | SAME | Aluminum |
| Seat size | ||
| Width | SAME | |
| Depth | ||
| Height | ||
| Back angle | ||
| adjustment | SAME | 20 degree |
| Seat-to-floor height | SAME | 18" |
| Incline | 12 degree | 6 degrees |
| Back upholstery | SAME | Fabric |
| Armrest types | SAME | Removable |
| Wheelchair Weight | 83.5 kg, batteries includes | 52.66 kg, batteries includes |
| Recharger | SAME | 24 VDC |
| (UL 1310 certified) | ||
| WHEEL LOCK | SAME | Switch to lock |
| Warranty | ||
| 3 years | SAME | |
| 1 year |
2
Image /page/2/Picture/0 description: The image shows a logo for Electric Medical Group. The logo features the letters EMG in a stylized font, with a silhouette of a running dog above the letters. The words "Electric Medical Group" are printed in a smaller font below the letters EMG. The logo is black and white.
EMG TECHNOLOGY CO., LTD. EMG TECHNOLOGY CO., LTD.
No.58, 35rd., Taichung Industrial Park,
Taiwan Tel:886-4-23596033
Fax:886-4-23596031 -
11:10
6 2017-01-1
- 11
C2
3
Image /page/3/Picture/0 description: The image shows a logo for Electric Medical Group. The logo features the letters EMG in a stylized font, with a panther leaping across the top of the letters. The words "ELECTRIC MEDICAL GROUP" are printed in a smaller font below the letters EMG. The logo is black and white.
EMG TECHNOLOGY CO., LTD.
No.58, 35rd., Taichung Industrial Park,
Taiwan
Tel:886-4-23596033
Fax:886-4-23596031
C.2 COMPARISON SUMMARY
( We place the related information for the predicate device in the following pages. )
We can know from the above table that the intended use between two devices is the same. The overall dimensions and visional appearance are similar. The batteries used are similar, i.e., U1 type. The control systems for the two devices are same supplier; it is Dynamic different controller types for the two devices. The recharge for the two devices are also used the same resource and the recharger is certified by UL 1310. The seat dimensions are same. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. The safety and performance functions of two systems are assured and validated. They are substantially equivalent.
The maximum cruising range is similar. This means the cruising range of the new device is 24 miles and 22 miles for the predicate device. This is mainly due to the fact that the batteries for the two devices are smaller. Certainly the real range depends on the practice environments. i.e., weight, surface, incline, and temperature. For the real life use, the two devices are substantially equivalent.
The maximum speed for the new device is 3.2 mph and 5.0 mph for the predicate device. Slower speed means the new device shall meet relevant requirements for the braking time, distance, and dynamic stability for safety considerations. The different maximum speeds do not lead any safety considerations and they are substantially equivalent in this aspect.
To sum up the mainly different of the two devices are only appearance dimensions, i.e., the frame, overall dimensions, and the size of wheels. For the regular operator, these differences for the two devices do not lead to any performance differences, and the three devices are substantially equivalent.
Based on the above the information and the analysis, we know that the subject device, the predicate device have the same intended use the same technological aspects and only minor dimensions and material differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.
4
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EMG Technology Co., Ltd. % Dr. Jen Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City, Taiwan, ROC
OCT 2 4 2006
Re: K062888
Trade/Device Name: Middle Wheel Drive Power, Chair CWD01 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 23, 2006 Received: September 26, 2006
Dear Dr. Ke-Min:
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. Ilisting 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.
5
Page 2 -- Dr. Jen Ke-Min
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,
Jubare Buekus
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510 (K) Number ( If Known ): _________________________________________________________________________________________________________________________________________________
Device Name: Middle Wheel Drive Power Chair, CWD01
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEE
Concurrence of CDRH, Office of Device Evaluation (ODE),
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
510(k) Number K062888