510(k) Report

Devices descending from K131327

14 later devices reach Bioarterial Plus Arterial Blood Flow Enhancement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.20250—
+1K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations201812—
+2K193550Therm-XZenith Technical Innovations202010—
+2K190854Therm-XZenith Technical Innovations201911—
+3K253150Cryon-X Cold CompressionJkh Health Co., Ltd.20250—
+3K223729FLOWpressoMedella Health Limited20233—
+3K223541Cold/Hot CompressionJkh Health Co., Ltd.20232—
+3K231912Therm-XZenith Technical Innovations20231—
+3K222136Cryo-Thermo Compression Device (FGK002)Suzhou Microport Rehabtech (Group) Co., Ltd.20230—
+4K232965Leg Massager (Models:RP-ALM070H, RP-ALM071H)Shenzhen Ruiyi Business Technology Co., Ltd.20242—
+4K240125Therm-X (Home); Therm-X (AT)Zenith Technical Innovations20240—
+4K240986Cold CompressionJkh Health Co., Ltd.20240—
+5K254200Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1…Wenzhou Lingfeng Electronic Technology Co., Ltd.20260—
+5K251662Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air…Shenzhen Future Electronic Co., Ltd.20250—