Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
INI — Predicate Candidate Screening
349 FDA 510(k) clearances under this product code; the 50 most recent screened below.
76 daysmedian FDA review time
275 days90th percentile
349clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261232 | IERO Mobility Scooter (IERO-01) | Jochu Technology Co., Ltd. | 2026-07-14 | 90 | 0 |
| K261163 | Mobility Scooter (R200) | Yongkang Ruihe Metal Product Co., Ltd. | 2026-07-07 | 89 | 0 |
| K253257 | Virgo Mobility Scooter (Virgo-D,Virgo-F) | Jiangsu Intco Medical Products Co., Ltd. | 2026-06-08 | 252 | 0 |
| K253600 | Scooter (YD-03) | Yurob Rehabilitation Medical Co., Ltd. | 2026-06-03 | 197 | 0 |
| K260717 | Mobility Scooter (Air Carbon) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | 2026-05-20 | 76 | 0 |
| K260237 | Mobility Scooter (X-12, X-14, X-17) | Wuyi Aichi Industry and Trade Co., Ltd. | 2026-04-22 | 86 | 0 |
| K252813 | Electrical Scooter (SM4226) | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. | 2026-03-17 | 194 | 0 |
| K253936 | Power Mobility Scooter (MJMA01, MJMA02) | Nanjing Mijo Technology Co., Ltd. | 2026-03-12 | 93 | 0 |
| K253631 | Mobility Scooter (CL-Q3, CL-Q4) | Zhejiang Wei Ling New Energy Technology Co., Ltd. | 2026-02-23 | 96 | 0 |
| K253643 | Mobility Scooter (S3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | 2026-02-18 | 91 | 0 |
| K252275 | Electric Scooter (DDF100) | Zhejiang Nysin Medical Co., Ltd. | 2026-01-29 | 191 | 0 |
| K252347 | Electric Scooter (Mojo-T580) | Dongguan Smarfody Mobility Technology Co., Ltd. | 2026-01-29 | 184 | 0 |
| K252349 | Electric Scooter (Mojo-T330) | Dongguan Smarfody Mobility Technology Co., Ltd. | 2026-01-29 | 184 | 0 |
| K253075 | Mobility scooter (Air Classic); Mobility scooter (Air Travel | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | 2026-01-09 | 108 | 0 |
| K252817 | Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd. | 2026-01-02 | 120 | 0 |
| K252835 | Electric Scooter (S202572J, S2060, M2089, S2050) | Guangdong Prestige Technology Co., Ltd. | 2025-12-23 | 109 | 0 |
| K252588 | Mobility Scooter (T5) | Zhejiang Taotao Vehicle Co., Ltd. | 2025-12-04 | 111 | 0 |
| K252590 | Powered Mobility Scooter (PMS105, GUT177, GCAT047) | Intradin (Shanghai) Machinery Co., Ltd. | 2025-11-21 | 98 | 0 |
| K252502 | Folding Mobility Scooter (KD101) | Nanjing Kangni Smart Technology Co., Ltd. | 2025-10-06 | 59 | 0 |
| K251799 | Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02) | Jiangsu Bangbang Intelligent Technology Co., Ltd. | 2025-09-30 | 110 | 0 |
| K251638 | Mobility Scooter (MS160C) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2025-07-22 | 54 | 0 |
| K243102 | Mobility Scooter (JT10) | Jiangxi Jiangte Electric Vehicle Co., Ltd. | 2025-06-18 | 261 | 0 |
| K250533 | Magnesium alloy scooter (RS100) | Taizhou Reach Technology Co., Ltd. | 2025-05-14 | 79 | 0 |
| K242975 | Mobility Scooter (Model X-01, X-02) | Wuyi Aichi Industry & Trade Co., Ltd. | 2025-05-07 | 223 | 0 |
| K250027 | Powered Mobility Scooter | Intradin (Shanghai) Machinery Co., Ltd. | 2025-02-21 | 46 | 0 |
| K242982 | Mobility Scooter (MS160A) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2025-01-31 | 127 | 0 |
| K242714 | Mobility Scooter (S-01); Mobility Scooter (S-02) | Zhejiang Seedream Medical Equipment Co., Ltd. | 2025-01-23 | 135 | 0 |
| K240590 | Electrical Scooter, WT-T4SU | W'U'S Tech Co., Ltd. | 2025-01-08 | 313 | 0 |
| K242139 | Mobility Scooter (YL-09B, YL-07) | Yongkang Yile Vehicle Co., Ltd. | 2025-01-06 | 168 | 0 |
| K242760 | WHILL Model R | Whill, Inc. | 2025-01-06 | 116 | 0 |
| K242628 | Scooter (PS30) | Lichtmega Technology Co., Ltd. | 2024-12-20 | 108 | 0 |
| K242387 | Mobility Scooter (N3473) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-10-11 | 60 | 0 |
| K240990 | Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-09-10 | 152 | 0 |
| K232692 | Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GU | Intradin (Shanghai) Machinery Co., Ltd. | 2024-09-05 | 366 | 0 |
| K240272 | Electric Scooter (M2085, S2091) | Guangdong Prestige Technology Co., Ltd. | 2024-07-16 | 167 | 0 |
| K240008 | Mobility Scooter (W3331) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-06-05 | 155 | 0 |
| K240012 | Mobility Scooter (W3431) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-05-02 | 121 | 0 |
| K234098 | Mobility Scooter (C4+) | Yongkang Yile Vehicle Co., Ltd. | 2024-04-18 | 114 | 0 |
| K231472 | Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | 2023-07-19 | 58 | 0 |
| K231428 | Mobility Scooter (Models: W3431D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023-07-14 | 58 | 0 |
| K230001 | Electric Scooter (Model: M2020) | Guangdong Prestige Technology Co., Ltd. | 2023-07-05 | 183 | 0 |
| K222703 | ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPO | Moving Life, Ltd. | 2023-05-19 | 254 | 0 |
| K230615 | Electric Scooter (Model: S3312) | Guangdong Prestige Technology Co., Ltd. | 2023-05-05 | 60 | 0 |
| K222729 | Electrical Scooter, WT-T4QP2 | Wu’S Tech Co., Ltd. | 2023-03-28 | 201 | 0 |
| K222507 | Mobility Scooter (Models: W3431Q, W3431R) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023-02-28 | 194 | 0 |
| K223492 | eFOLDi Scooter, Lite | Suntech UK , Ltd. | 2023-02-22 | 93 | 0 |
| K222711 | HS186B Scooter | Suzhou Master Machinery Manufacturing Co.,Ltd | 2023-01-09 | 123 | 0 |
| K222495 | Mobility Scooter, Model: W3331F | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022-10-17 | 60 | 0 |
| K220227 | Auto Folding Scooter, S21F | Heartway Medical Products Co., Ltd. | 2022-10-12 | 258 | 0 |
| K212090 | Electric Scooter | Anhui Jbh Medical Apparatus Co., Ltd. | 2022-04-22 | 290 | 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