What is FDA product code ITI?

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. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).

Physical Medicine › ProstheticWheelchair, Powered

Power-Flex

Name: Power-Flex
Brand: Power-Flex

Power-Flex is a powered drive attachment that converts a compatible rigid-frame manual wheelchair to joystick-controlled mobility. It is intended for disabled users who can operate both…

Registry build 21.09.26

Power-Flex is a powered drive attachment that converts a compatible rigid-frame manual wheelchair to joystick-controlled mobility. It is intended for disabled users who can operate both powered and manual wheelchairs. The system replaces the manual chair’s rear wheels while retaining its front casters.

Two motors drive the attached wheels, with a microprocessor controlling speed, acceleration, deceleration and braking in response to the joystick. The drive assembly connects through the chair’s axle receivers and a rear clamp on its rigidizer bar.

Drive Configuration

The system includes batteries, controls, a power supply, stabilizing caster wheels and a manual tilt mechanism that also limits tipping. Its stated maximum user weight is 275 pounds, and it uses rechargeable lead-acid batteries.

62manufacturers in China registered for this device type

3catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Zhejiang (23), Jiangsu (14), Guangdong (10). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ITI
Manufacturer	City	Province	Registered as	Device types
Merits Healthcare Industries. (Suzhou) Co., Ltd.	Jiangsu	Jiangsu	Contract manufacturer	31
Chiaphua Components (Jiangxi) Limited	Yichun	Jiangxi	Contract manufacturer	23
Feishen Group Co., Ltd.	Yongkang	Zhejiang	Contract manufacturer	22
Guangdong Marshell Electric Vehicle Co., Ltd.	Zhaoqing	Guangdong	Contract manufacturer	22
Viscount HI-Tech (Huizhou) Co., Ltd.	Huizhou	Guangdong	Contract manufacturer	17
Zhejiang Linix Motor Co., Ltd.	Dongyang	Zhejiang	Contract manufacturer	4
Jiangsu Bangbang Intelligent Technology Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	2
Jinhua Ruidi Vehicle Industry Co Ltd	Zhejiang	Zhejiang	Contract manufacturer	2
Suzhou Green Pine Medical Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	2
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.	Danyang	Jiangsu	Contract manufacturer	37
Kunshan Hi-Fortune Health Products Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	32
Zhenjiang Assure Medical Equipment Co Ltd	Zhenjiang	Jiangsu	Contract manufacturer	18

Showing 12 of 62. All 62 manufacturers in China registered for Wheelchair, Powered

Record

Regulatory record for Power-Flex
Listed by	Soul Mobility, Inc, United States
FDA product code	ITI
Device type	Wheelchair, Powered
Device class	Class 2
Regulation	21 CFR 890.3860
Establishment	Specification developer, Manufacturer
510(k)	K242430
Record published	2025-03-14

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Power-Flex
Catalogue number	Size	Status
PFX1820		In distribution
PFX1517		In distribution
PFX1214		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Merits	Merits Health Products, Inc.	186
e-motion®	Alber Gmbh	129
Modular Power Positioning System	Motion Concepts	112
e-fix®	Alber Gmbh	56
TRZ-CG Power Positioning System	Motion Concepts	54
Batec	Batec Mobility SL.	48
Drive	Drive DeVilbiss Healthcare	47
Invacare® TDX® Power Wheelchair	Invacare GmbH	43
Drivemedical	Drive DeVilbiss Healthcare	34
Heartway Medical Products Co., Ltd.	Heartway Medical Products Co., Ltd.	20
Scout	Burke, Inc.	20
Power Wheelchair	Zhejiang Innuovo Rehabilitation Devices Co., Ltd.	18

Showing 12 of 277. All products under Wheelchair, Powered

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K242430	2024-11-12

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.