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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a powered wheelchair, the Middle Wheel Drive Power Chair, CWD01. The submission focuses on demonstrating substantial equivalence to a predicate device (EPW POWERED WHEELCHAIR GP-201, K023148) rather than presenting a study to prove the device meets specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not present in this document, as they are typically associated with performance studies for novel devices or when demonstrating clinical superiority/non-inferiority.

Based on the provided information, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study. Instead, it compares the subject device's specifications to those of a predicate device to demonstrate substantial equivalence. The "performance testing" mentioned refers to compliance with safety and electrical standards, not specific clinical performance metrics.

ITEM	Subject Device (CWD01)	Predicate Device (GP-201)	Comments
Intended Use	Same	Provide mobility to persons restricted to a sitting position	Claimed to be the same.
Overall length	90 cm / 35.4"	38"	Similar, minor dimensional difference.
Overall width	65 cm / 25.6"	24"	Similar, minor dimensional difference.
Overall Height	113 cm / 44.5"	18" from seat	Not directly comparable due to different measurement points, but overall dimensions are considered similar.
Weight limit	136 kgs / 300 lbs	350 lbs	Subject device has a lower weight limit.
Maximum speed	5 km/hr (3.2 mph)	5.0 mph	Subject device is slower; considered acceptable as slower speed does not raise new safety concerns.
Electronics	Dynamic Shark controller	Dynamic DL controller	Different controller types from the same supplier ("Dynamic"). Claimed to be substantially equivalent.
Batteries Type	U1, 35Ah gel cell 12VDC	U1, 30Ah gel cell 12VDC	Similar U1 type, subject device has slightly higher Ah.
Range per charge	24 miles (40 km)	22 miles	Similar, subject device has slightly higher range due to battery difference.
Recharger	SAME	24 VDC (UL 1310 certified)	Same resource, certified by UL 1310.
Incline	12 degree	6 degrees	Subject device handles a steeper incline.
Other Standards	ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995	Not explicitly stated but assumed to meet relevant standards for a predicate.	Compliance with these standards indicates meeting safety and performance aspects for powered wheelchairs.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) submission based on substantial equivalence to a predicate device, not a performance study involving a patient test set. The "performance testing" refers to engineering and safety standard compliance, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There was no clinical test set for which ground truth needed to be established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a powered wheelchair and does not involve AI or human readers for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a powered wheelchair, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. There was no clinical test set requiring ground truth. The "ground truth" here is compliance with established engineering and safety standards for powered wheelchairs.

8. The sample size for the training set

Not applicable. There was no training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable. There was no training set. The "ground truth" for the device's design and manufacturing is adherence to regulatory and industry standards for safety and performance of powered wheelchairs.

Summary

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K062888

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:

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 )

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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 isintended for medicalpurposes to providemobility to personsrestricted to a sittingposition.
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
	DepthHeight
Back angleadjustment	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

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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

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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.

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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.

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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

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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

Regulation Number and Section

§ 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).