Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
ITI — Predicate Candidate Screening
585 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
255 days90th percentile
585clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261149 | Electric Wheelchair (DY611A-2, DY612A-1) | Zhejiang Lumbre Electric Appliance Co., Ltd. | 2026-07-10 | 93 | 0 |
| K261396 | Electric Wheelchair | Ningbo Resshidi Medical Devices Co., Ltd. | 2026-07-08 | 70 | 0 |
| K261164 | Electric wheelchair (XW-LY007 ) | Yongkang Ruihe Metal Product Co., Ltd. | 2026-07-07 | 89 | 0 |
| K260937 | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK | Shanghai Waylong Intelligent Technology Co.,Ltd | 2026-06-24 | 96 | 0 |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-18 | 202 | 0 |
| K260335 | Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 2026-06-15 | 133 | 0 |
| K261175 | WHILL (WHILL Model C2) | Whill, Inc. | 2026-06-12 | 63 | 0 |
| K260056 | Power Wheelchair (N5515A, N5516, N5517A, N5519) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-05 | 148 | 0 |
| K260373 | Electric Wheelchair (DF506) | Jiangsu Yveelt Medical Equipment Co., Ltd. | 2026-06-03 | 118 | 0 |
| K253241 | Electric Wheelchair (Y207BL) | Jiangsu Intco Medical Products Co., Ltd. | 2026-05-13 | 226 | 0 |
| K253806 | Power Wheelchair (N5919 series) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-04-20 | 143 | 0 |
| K253952 | Power Wheelchair (OS-R-M01S) | Beijing OrionStar Technology Co., Ltd. | 2026-04-07 | 118 | 0 |
| K253340 | Electric Wheelchair (AL-208S-063) | Zhongshan A&J Medical Equipment Co., Ltd. | 2026-04-03 | 185 | 0 |
| K253307 | Electric wheelchair | Foshan Dahao Medical Technology Co., Ltd. | 2026-03-27 | 179 | 0 |
| K254206 | Power wheelchair (ZS-EW8026) | Ningbo Zhishan Medical Technology Co., Ltd. | 2026-03-27 | 88 | 0 |
| K253980 | Electrically Powered Wheelchair (Model YC-01) | Yurob Rehabilitation Medical Co., Ltd. | 2026-03-27 | 105 | 0 |
| K254012 | Electric Wheelchair (E201) | Nanjing CareMoving Rehabilitation Equipment Co.,Ltd | 2026-03-24 | 99 | 0 |
| K253849 | Electric wheelchair (JJW-7002, JJW-7003) | ZheJiang J&J Mobility Co., Ltd. | 2026-03-20 | 108 | 0 |
| K252101 | JWG-1 | Yamaha Motor Co., Ltd. | 2026-03-19 | 259 | 0 |
| K253870 | Electric Wheelchair (MP148) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2026-03-04 | 90 | 0 |
| K253789 | Electric wheelchair | Zhejiang Yikang Medical Technology Co., Ltd. | 2026-02-25 | 89 | 0 |
| K253707 | Electric wheelchair (W1,W3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | 2026-02-24 | 92 | 0 |
| K253599 | Electric Wheelchair (W-A807, W-A807L) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2026-02-17 | 91 | 0 |
| K253276 | Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wh | Shanghai Bangbang Robotics Co., Ltd. | 2026-01-15 | 108 | 0 |
| K251458 | Electric Wheelchair (DH01168) | Foshan Dahao Medical Technology Co., Ltd. | 2026-01-15 | 248 | 0 |
| K251159 | Power wheelchair | Zhenjiang Assure Medical Equipment Co., Ltd. | 2025-12-22 | 251 | 0 |
| K252862 | Electric Wheelchair (DH01126) | Foshan Dahao Medical Technology Co., Ltd. | 2025-12-08 | 90 | 0 |
| K252494 | Electrically powered wheelchair (KZ301B) | Nanjing Kangni Smart Technology Co., Ltd. | 2025-12-05 | 119 | 0 |
| K252829 | Powered Wheelchair (PL001-9001) | Suzhou KD Intelligent Device Co., Ltd. | 2025-11-12 | 68 | 0 |
| K250819 | Electric Wheelchair (Rollz Motion Electric 2M) | Rollz International BV | 2025-11-07 | 234 | 0 |
| K252671 | Electric wheelchair (NSDS-01) | Hebei Dansong Medical Technology Co., Ltd. | 2025-11-03 | 70 | 0 |
| K251565 | Wheelchair (N817) | Zhejiang Topwe Tools Manufacturing Co.,Ltd | 2025-10-06 | 137 | 0 |
| K252428 | Electric Wheelchair (Model P2) | Superpi Robot Co., Ltd. | 2025-09-18 | 48 | 0 |
| K251891 | Electric Wheelchair (GY-E001) | Shandong Guyue Healthcare Appliance Co., Ltd. | 2025-09-09 | 81 | 0 |
| K250729 | Power Wheelchair (MOB1107) | Vive Health, LLC | 2025-07-02 | 113 | 0 |
| K251285 | Electric Wheelchair (HG-630) | Zhejiang Automwheel Tech Co., Ltd. | 2025-07-02 | 68 | 0 |
| K251606 | Power Wheelchair (D26) | Anhui Jbh Medical Apparatus Co., Ltd. | 2025-06-25 | 29 | 0 |
| K251248 | ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02) | Jinhua Qidian Vehicle Co., Ltd. | 2025-06-20 | 58 | 0 |
| K250475 | Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EAL | Ningbo Baichen Medical Devices Co., Ltd. | 2025-05-27 | 97 | 0 |
| K250758 | Electric Wheelchair (F309) | Changshu Pingfang Wheelchair Co., Ltd. | 2025-05-09 | 57 | 0 |
| K243110 | eFOLDi Navigator Powerchair (STPC-A) | Suntech UK , Ltd. | 2025-05-08 | 220 | 0 |
| K250158 | Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003) | Zhe Jiang Cleisman Industry and Trade Co.,Ltd | 2025-04-28 | 97 | 0 |
| K250748 | KLAXON (TWIST); KLAXON (TWIST R) | Klaxon-Mobility GmbH | 2025-04-11 | 30 | 0 |
| K250366 | Electric Wheelchair (LW01301A07) | Anhui Longway Medical Technology Co., Ltd. | 2025-04-08 | 57 | 0 |
| K242358 | Powered wheelchair (mobility robot) (M4, M4U) | Xsto Co., Ltd. | 2025-04-03 | 238 | 0 |
| K250134 | Power Wheelchair (YH-E6011,YH-E6013A) | Ningbo Youhuan Automation Technology Co., Ltd. | 2025-03-26 | 68 | 0 |
| K244003 | Electrically powered wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | 2025-03-26 | 90 | 0 |
| K243970 | Portable Wheelchair | Intradin (Shanghai) Machinery Co., Ltd. | 2025-03-07 | 74 | 0 |
| K241159 | Handbike Batec Electric | Batec Mobility, S.L. | 2025-03-07 | 315 | 0 |
| K243961 | Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | 2025-02-12 | 51 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda