Wenzhou Lingfeng Electronic Technology Co., Ltd. · Class II · Cleared May 5, 2026
| K-number | K254200 |
| Device name | Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14) |
| Applicant | Wenzhou Lingfeng Electronic Technology Co., Ltd. |
| Product code | IRP |
| Device class | Class II |
| Decision date | May 5, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 890.5650 |
The Air Compression Leg Massager is a home healthcare device consisting of a controller, adapter, and two leg sleeves with three air chambers each (thigh, calf, foot). It provides sequential or peristaltic air compression massage to temporarily relieve minor muscle aches and pains and increase circulation in the legs. It also includes adjustable heating function for the feet and knees, with pressure and temperature adjustable across three levels.
The subject device differs from the predicate in several ways: it offers both sequential and peristaltic compression modes (predicate has sequential only); faster inflation/deflation times (0.6–13s inflation vs. 3–30s); different heating sites (knees and feet vs. calves and feet); three working modes versus six in the predicate; and adjustable sleeve sizes with Velcro design. Pressure range is 0–31 kPa (similar to predicate's 0–240 mmHg), and treatment time is 20 minutes for both.
IEC 60601-1:2005+A1:2012+A2:2020 (general electrical safety); IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility); IEC 60601-1-11:2015+A1:2020 (home healthcare environment); ISO 10993-5:2009 (in vitro cytotoxicity); ISO 10993-10:2021 (skin sensitization); ISO 10993-23:2021 (irritation testing); software verification and validation testing.
The subject device has identical indications for use and similar core technology (compressor and valve system inflating chambers) as the predicate device (K232965). Although specifications differ in compression modes, inflation times, heating sites, and modes, the applicant demonstrates through testing and analysis that these differences do not affect safety or effectiveness: final pressure outputs are equivalent, treatment time is the same, all safety and performance testing conforms to standards, and biocompatibility is demonstrated. Therefore, the device is substantially equivalent despite technological differences.
View the full FDA submission: accessdata.fda.gov