Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IRP — Predicate Candidate Screening
155 FDA 510(k) clearances under this product code; the 50 most recent screened below.
115 daysmedian FDA review time
326 days90th percentile
155clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260529 | Air Compression Massager (HY-1165) | Xiamen High Top Electronic Technology Co., Ltd. | 2026-07-27 | 160 | 0 |
| K260948 | Air Compression Massager (EP30B001 I) | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | 2026-07-24 | 123 | 0 |
| K253919 | Cryo And Thermo Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2026-06-10 | 184 | 0 |
| K252396 | Cryo Sport 2.0 (AVA 501) | Avanutri Equipamentos DE Saúde | 2026-05-29 | 302 | 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 |
| K252386 | Hot and Cold Compression System (A02-C-032) | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2026-04-03 | 246 | 0 |
| K253076 | Cryopush Cold Compression Device (A02-P-001) | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2026-04-02 | 191 | 0 |
| K251622 | Hand Massager (SM004D) | Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. | 2026-01-28 | 245 | 0 |
| K251662 | Air Compression Therapy Device (ST-504); Air Compression The | Shenzhen Future Electronic Co., Ltd. | 2025-11-13 | 167 | 0 |
| K251531 | AIR COMPRESSION BOOTS 1018195,1018196 | Merchsource, LLC | 2025-10-30 | 164 | 0 |
| K253150 | Cryon-X Cold Compression | Jkh Health Co., Ltd. | 2025-10-24 | 29 | 0 |
| K251905 | Normatec Elite Hip | NormaTec Industries, LP | 2025-09-18 | 90 | 0 |
| K251623 | Air Compression Therapy Device (K1002/K1006/K1007/K1008/K106 | Shenzhen Yicai Health Technology Co., Ltd. | 2025-09-17 | 112 | 0 |
| K250244 | Compression Therapy Device (LGT-2210DS) | Guangzhou Longest Medical Technology Co., Ltd. | 2025-07-25 | 179 | 0 |
| K242615 | Intermittent pressure compression system (Compression Pump P | Xiamen Taotao Technology Co., Ltd. | 2025-07-23 | 323 | 0 |
| K242754 | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | Zamar Medical D.O.O. | 2025-05-05 | 235 | 0 |
| K250046 | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM6 | Shenzhen Urion Technology Co., Ltd. | 2025-04-25 | 105 | 0 |
| K242140 | Air Compression Leg Massager (K-705) | Jiale Health Technology Shenzhen Co., Ltd. | 2025-03-17 | 238 | 0 |
| K243206 | Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS | Sichuan Qianli-Beoka Medical Technology, Inc. | 2025-02-19 | 141 | 0 |
| K243572 | Game Ready system (550500-04); Game Ready Control Unit (5505 | Avanos Medical, Inc. | 2025-01-31 | 74 | 0 |
| K243791 | Air Pressure Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2025-01-13 | 34 | 0 |
| K243177 | SACS PRO | Elastimed , Ltd. | 2024-12-23 | 84 | 0 |
| K232965 | Leg Massager (Models:RP-ALM070H, RP-ALM071H) | Shenzhen Ruiyi Business Technology Co., Ltd. | 2024-11-20 | 426 | 0 |
| K243320 | Air Pressure Therapy System (VU-IPC04B) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2024-11-18 | 26 | 0 |
| K242940 | Xrecovery (XR-001) | Shenzhen Xinrun Electric Appliances Co, Ltd. | 2024-11-14 | 50 | 0 |
| K241446 | Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) | Sichuan Qianii-Beoka Medical Technoiogy Lnc. | 2024-10-08 | 139 | 0 |
| K240373 | Air compression Leg Massager (MM0520, MM0521, MM0522) | Zhangzhou Easepal Medical Science and Technology Co., Ltd. | 2024-09-17 | 223 | 0 |
| K241256 | JetBoots PRO Plus | Therabody, Inc. | 2024-08-30 | 116 | 0 |
| K240981 | Air compression leg massager | Huizhou Xinyi Technology Co., Ltd. | 2024-08-02 | 114 | 0 |
| K233238 | Air Pressure Therapy System (Model:VU-IPC4M) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2024-06-14 | 260 | 0 |
| K240986 | Cold Compression | Jkh Health Co., Ltd. | 2024-05-01 | 21 | 0 |
| K240122 | Normatec Elite | NormaTec Industries, LP | 2024-03-21 | 65 | 0 |
| K230524 | Cold Compression Wrap Pro | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2024-01-19 | 326 | 0 |
| K223729 | FLOWpresso | Medella Health Limited | 2023-12-21 | 373 | 0 |
| K233536 | Air Compression Recovery System | Shenzhen Dongjilian Medical Tech Co., Ltd. | 2023-12-16 | 43 | 0 |
| K223541 | Cold/Hot Compression | Jkh Health Co., Ltd. | 2023-10-27 | 336 | 0 |
| K230500 | Air Compression Therapy Recovery System (model: MF-AWI, MF-A | Jiangsu Maxf Electric Appliance Co., Ltd. | 2023-10-26 | 244 | 0 |
| K231912 | Therm-X | Zenith Technical Innovations | 2023-07-27 | 28 | 0 |
| K231437 | LF900 | Daesung Maref Co., Ltd. | 2023-07-19 | 63 | 0 |
| K230385 | Ballancer Platinum (1222) | Mego Afek | 2023-04-04 | 49 | 0 |
| K222991 | Air Compression Leg Massager (model: EMK-701) | Xiamen Emoka Health Science & Technology Co., Ltd. | 2023-03-15 | 168 | 0 |
| K223464 | Leg and Foot Air Wave Pressure Therapy Device | Zhangzhou Easepal Innovation CO , Ltd. | 2023-03-14 | 117 | 0 |
| K222136 | Cryo-Thermo Compression Device (FGK002) | Suzhou Microport Rehabtech (Group) Co., Ltd. | 2023-03-08 | 232 | 0 |
| K222924 | Leg Massager RF-ALM070 | Shenzhen Ruiyi Business Technology Co., Ltd. | 2022-12-23 | 88 | 0 |
| K222949 | Air Compression Leg Massager (Model: LY-670D) | Zhejiang Luyao Electronics Technology Co., Ltd. | 2022-12-22 | 86 | 1 |
| K221862 | YY-A02-B Overlapped Compression Therapy | Huizhou Xinyi Technology Co., Ltd. | 2022-12-08 | 164 | 0 |
| K222669 | Cryopush Cold Compression Device | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2022-12-05 | 90 | 0 |
| K223164 | Aquilo Sports CCT1500 System | Aquilo Sports, LLC | 2022-11-04 | 28 | 0 |
| K222206 | Air Compression Leg Massager (Models: S9036C, S9036B and S90 | Shenzhen Dongjilian Medical Tech Co., Ltd. | 2022-09-30 | 67 | 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