510(k) Report

Devices descending from K190854

11 later devices reach Therm-X through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193550Therm-XZenith Technical Innovations202010—
+2K253150Cryon-X Cold CompressionJkh Health Co., Ltd.20250—
+2K223729FLOWpressoMedella Health Limited20233—
+2K223541Cold/Hot CompressionJkh Health Co., Ltd.20232—
+2K231912Therm-XZenith Technical Innovations20231—
+2K222136Cryo-Thermo Compression Device (FGK002)Suzhou Microport Rehabtech (Group) Co., Ltd.20230—
+3K232965Leg Massager (Models:RP-ALM070H, RP-ALM071H)Shenzhen Ruiyi Business Technology Co., Ltd.20242—
+3K240125Therm-X (Home); Therm-X (AT)Zenith Technical Innovations20240—
+3K240986Cold CompressionJkh Health Co., Ltd.20240—
+4K254200Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1…Wenzhou Lingfeng Electronic Technology Co., Ltd.20260—
+4K251662Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air…Shenzhen Future Electronic Co., Ltd.20250—