Merits Model R Series Positioning System for Powered Wheelchair
FDA 510(k) K113577 · Merits Health Products Co., Ltd.
Submission
- Device name
- Merits Model R Series Positioning System for Powered Wheelchair
- Applicant
- Merits Health Products Co., Ltd.
Taichung, TW - Received
- December 5, 2011
- Decision date
- May 8, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ITI – Wheelchair, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3860
- Specialty
- Physical Medicine
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…
Other 510(k)s with product code ITI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260229 | Electric wheelchair (HC819N, HC830N, HC831N)ITI · Traditional | Yongkang Hengyi Vehicle Co., Ltd. | 09/08/2026SE |
| K260053 | Power Wheelchair (OS-R-M01I)ITI · Traditional | Beijing OrionStar Technology Co., Ltd. | 09/08/2026SE |
| K261354 | Electric wheelchair (D03)ITI · Traditional | Foshan Sowell Medical Technology Co., Ltd. | 08/21/2026SE |
| K261149 | Electric Wheelchair (DY611A-2, DY612A-1)ITI · Traditional | Zhejiang Lumbre Electric Appliance Co., Ltd. | 07/10/2026SE |
| K261396 | Electric WheelchairITI · Traditional | Ningbo Resshidi Medical Devices Co., Ltd. | 07/08/2026SE |
| K261164 | Electric wheelchair (XW-LY007 )ITI · Traditional | Yongkang Ruihe Metal Product Co., Ltd. | 07/07/2026SE |
| K260937 | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)ITI · Traditional | Shanghai Waylong Intelligent Technology Co.,Ltd | 06/24/2026SE |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D)ITI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 06/18/2026SE |
| K260335 | Electric Wheelchair (S500-6)ITI · Traditional | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 06/15/2026SE |
| K261175 | WHILL (WHILL Model C2)ITI · Traditional | Whill, Inc. | 06/12/2026SE |
More from Whill, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K220529 | Merits P335 Powered WheelchairITI · Abbreviated | 03/18/2022SE |
| K142912 | Merits Yoga Power Scooter, S542INI · Abbreviated | 06/23/2015SE |
| K142162 | Merits Transformer Power Scooter, S941INI · Traditional | 05/01/2015SE |
| K122357 | Merits Model P322FWD Powered WheelchairITI · Abbreviated | 01/09/2013SE |
| K092859 | Merits Model N Series Nebulizer CompressorsCAF · Abbreviated | 07/02/2010SE |
| K091716 | Merits Health Products Profil Q601 Series Oxygen Filling AccessoryCAW · Special | 04/02/2010SE |
| K073110 | Merits E600 Series Stair LiftILK · Traditional | 02/06/2008SE |
| K073513 | Merits E700 Porce LiftING · Abbreviated | 01/14/2008SE |
| K053490 | Merits Health Products Portable NebulizerCAF · Abbreviated | 07/24/2006SE |
| K053230 | Merits Health Products Oxygen ConcentratorsCAW · Traditional | 05/16/2006SE |
Questions and answers
When was Merits Model R Series Positioning System for Powered Wheelchair cleared by the FDA?
Merits Model R Series Positioning System for Powered Wheelchair (K113577) received a 510(k) decision of Substantially Equivalent on May 8, 2012, 155 days after the submission was received.
What is the product code of K113577?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.