Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Physical Medicine — Predicate Candidate Screening
5,638 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
116 daysmedian FDA review time
309 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261571 | Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-08-06 | 86 | 0 |
| K260381 | Eve | Wandercraft SAS | 2026-08-03 | 179 | 0 |
| K260529 | Air Compression Massager (HY-1165) | Xiamen High Top Electronic Technology Co., Ltd. | 2026-07-27 | 160 | 0 |
| K250419 | Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable P | Plus EV Holdings, Inc. D/B/A Intimate Rose | 2026-07-27 | 529 | 0 |
| K252370 | GEN 4 JOY Wheelchair | Free Wheelchair Mission | 2026-07-24 | 359 | 0 |
| K260948 | Air Compression Massager (EP30B001 I) | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | 2026-07-24 | 123 | 0 |
| K261675 | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK- | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | 2026-07-17 | 57 | 0 |
| K261232 | IERO Mobility Scooter (IERO-01) | Jochu Technology Co., Ltd. | 2026-07-14 | 90 | 0 |
| 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 |
| K261163 | Mobility Scooter (R200) | Yongkang Ruihe Metal Product Co., Ltd. | 2026-07-07 | 89 | 0 |
| K261253 | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5 | Ziree Co., Ltd. | 2026-06-26 | 71 | 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 |
| K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted whee | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 | 82 | 0 |
| K261075 | Manual Wheelchair (MS01);Manual Wheelchair (MA01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 | 82 | 0 |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-18 | 202 | 0 |
| K260899 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F2 | Zdeer Technology (Henan) Co., Ltd. | 2026-06-16 | 90 | 0 |
| K253231 | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, L | Hubei Yjt Technology Co.,Ltd | 2026-06-16 | 260 | 0 |
| K260335 | Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 2026-06-15 | 133 | 0 |
| K252963 | BTL-899TT | BTL Industries, Inc. | 2026-06-12 | 268 | 0 |
| K261175 | WHILL (WHILL Model C2) | Whill, Inc. | 2026-06-12 | 63 | 0 |
| K260849 | ICON 35; ICON 45; ICON 60; ICON 30FAF | Rehasense USA, Inc. | 2026-06-11 | 87 | 0 |
| K253919 | Cryo And Thermo Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2026-06-10 | 184 | 0 |
| K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026-06-08 | 206 | 0 |
| K253257 | Virgo Mobility Scooter (Virgo-D,Virgo-F) | Jiangsu Intco Medical Products Co., Ltd. | 2026-06-08 | 252 | 0 |
| K251684 | Alma TED+ System | Alma Lasers, Inc. | 2026-06-05 | 368 | 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 |
| K253600 | Scooter (YD-03) | Yurob Rehabilitation Medical Co., Ltd. | 2026-06-03 | 197 | 0 |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP) | Mohammadali Nezakati | 2026-06-02 | 271 | 0 |
| K260642 | Manual Wheelchair (LW01108) | Anhui Longway Medical Technology Co., Ltd. | 2026-06-02 | 95 | 0 |
| K252396 | Cryo Sport 2.0 (AVA 501) | Avanutri Equipamentos DE Saúde | 2026-05-29 | 302 | 0 |
| K260295 | Helio Kids; Apex P | Motion Composites | 2026-05-28 | 119 | 0 |
| K260142 | StimelMD (SSMD) system | Motion Informatics ltd. | 2026-05-27 | 127 | 0 |
| K254141 | Manual Wheelchair (DY01903(2)) | Guangdong Dayang Medical Technology Co., Ltd. | 2026-05-21 | 150 | 0 |
| K260717 | Mobility Scooter (Air Carbon) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | 2026-05-20 | 76 | 0 |
| K254024 | MR5 Activ Pro | Multi Radiance Medical, Inc. | 2026-05-19 | 154 | 0 |
| K253241 | Electric Wheelchair (Y207BL) | Jiangsu Intco Medical Products Co., Ltd. | 2026-05-13 | 226 | 0 |
| K254200 | Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003 | Wenzhou Lingfeng Electronic Technology Co., Ltd. | 2026-05-05 | 127 | 0 |
| K253064 | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2026-04-30 | 220 | 0 |
| K260076 | SAM 3.0 Multi-Hour Continuous Ultrasound Device | ZetrOZ Systems, LLC | 2026-04-28 | 106 | 0 |
| K260121 | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 2026-04-28 | 103 | 0 |
| K260237 | Mobility Scooter (X-12, X-14, X-17) | Wuyi Aichi Industry and Trade Co., Ltd. | 2026-04-22 | 86 | 0 |
| K253638 | xStep (xStep) | Spinex, Inc. | 2026-04-20 | 152 | 0 |
| K253806 | Power Wheelchair (N5919 series) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-04-20 | 143 | 0 |
| K253926 | Diacore | ShenB Co., Ltd. | 2026-04-10 | 123 | 0 |
| K253952 | Power Wheelchair (OS-R-M01S) | Beijing OrionStar Technology Co., Ltd. | 2026-04-07 | 118 | 0 |
| K252386 | Hot and Cold Compression System (A02-C-032) | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2026-04-03 | 246 | 0 |
| K253340 | Electric Wheelchair (AL-208S-063) | Zhongshan A&J Medical Equipment Co., Ltd. | 2026-04-03 | 185 | 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