510(k) Report

Devices descending from K013436

55 later devices reach Normatec PCD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161346NormaTec PCD-T and PCD-BNormaTec Industries, LP20161—
+1K112890Normatec MVPNormaTec Industries, LP201252—
+2K183328Pulse Rx 2.0, Pulse Pro Rx 2.0NormaTec Industries, LP20180—
+2K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP201651—
+3K212169Air compression therapy system FO3002Foshan Hongfeng Co., Ltd.20210—
+3K201935Air Pressure Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd.20214—
+3K210967Air Pressure Therapy System: VU-IPC06Xiamen Weiyou Intelligent Technology Co., Ltd.20210—
+3K201982Air compression therapy system FO-3001; Air compression therapy system FO-3008Foshan Hongfeng Co., Ltd.20213—
+3K193354Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd.202020—
+3K191862Compression Therapy Device Model LGT-2200SPGuangzhou Longest Science & Technology Co., Ltd.20191—
+3K183169Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP201810—
+3K182668Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC201838—
+4K260529Air Compression Massager (HY-1165)Xiamen High Top Electronic Technology Co., Ltd.20260—
+4K251531Air Compression Boots 1018195,1018196Merchsource, LLC20250—
+4K232965Leg Massager (Models:RP-ALM070H, RP-ALM071H)Shenzhen Ruiyi Business Technology Co., Ltd.20242—
+4K230500Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801…Jiangsu Maxf Electric Appliance Co., Ltd.20231—
+4K222991Air Compression Leg Massager (model: EMK-701)Xiamen Emoka Health Science & Technology Co., Ltd.20232—
+4K223464Leg and Foot Air Wave Pressure Therapy DeviceZhangzhou Easepal Innovation CO, Ltd.20230—
+4K222924Leg Massager RF-ALM070Shenzhen Ruiyi Business Technology Co., Ltd.20220—
+4K221862YY-A02-B Overlapped Compression TherapyHuizhou Xinyi Technology Co., Ltd.20220—
+4K222669Cryopush Cold Compression DeviceChengdu Cryo-Push Medical Technology Co.,Ltd20222—
+4K223164Aquilo Sports CCT1500 SystemAquilo Sports, LLC20220—
+4K201730Powered Inflatable Tube Massager - SLIM UP DRAINFoggiare Technologies, LLC20220—
+4K213745Air Compression Therapy Device, model: ST-502Shenzhen Future Electronic Co., Ltd.20223—
+4K211850Air Compression Leg Massager (model: FE-7204B)Xiamen Healthpal Electronic Co.,Ltd20220—
+4K220217Normatec 3NormaTec Industries, LP20227—
+4K212935Air Pressure Foot MassagerXiamen Simo Electronic Co., Ltd.20223—
+4K212713Air compression leg massager HY-1117AXiamen High Top Electronic Technology Co., Ltd.20220—
+4K211283Compressible Limb and Circulation Therapy System, Model POWER-Q2300Wonjin Mulsan Co., Ltd.20211—
+4K202395SP-1000, SP-2000Daesung Maref Co., Ltd.20210—
+4K203498LX9maxDaesung Maref Co., Ltd.20210—
+4K210281Fist Assist Devices Model FA-1Fist Assist Devices, LLC20210—
+4K200660Compressible Limb and Circulation Therapy SystemWonjin Mulsan Co., Ltd.20210—
+4K191441Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)Maxstar Industrial Co., Ltd.20212—
+4K203552Rapid RebootRapid Reboot Recovery Products, LLC20201—
+4K201645Massage Compression BootsJkh USA, LLC20200—
+4K192358Pressure Therapy System PT1003Xiamen Senyang Co., Ltd.202001
+4K192252ProPerformance Recovery SystemMenlo Brands, LLC20190—
+5K260948Air Compression Massager (EP30B001 I)Wavepulse (Xiamen) Healthcare Technology Co., Ltd.20260—
+5K254200Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1…Wenzhou Lingfeng Electronic Technology Co., Ltd.20260—
+5K253076Cryopush Cold Compression Device (A02-P-001)Chengdu Cryo-Push Medical Technology Co.,Ltd20260—
+5K251622Hand Massager (SM004D)Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.20260—
+5K251662Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air…Shenzhen Future Electronic Co., Ltd.20250—
+5K250046Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)Shenzhen Urion Technology Co., Ltd.20250—
+5K242140Air Compression Leg Massager (K-705)Jiale Health Technology Shenzhen Co., Ltd.20250—
+5K233238Air Pressure Therapy System (Model:VU-IPC4M)Xiamen Weiyou Intelligent Technology Co., Ltd.20240—
+5K240122Normatec EliteNormaTec Industries, LP20243—
+5K230524Cold Compression Wrap ProChengdu Cryo-Push Medical Technology Co.,Ltd20240—
+5K221666Normatec GoNormaTec Industries, LP20222—
+5K211460Air Relax Plus Model AR-3.0Diode Art Engineering Doing Business AS Air Relax20211—
+6K251905Normatec Elite HipNormaTec Industries, LP20250—
+6K243206Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4…Sichuan Qianli-Beoka Medical Technology, Inc.20250—
+6K243177Sacs ProElastimed, Ltd.20240—
+6K241446Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)Sichuan Qianii-Beoka Medical Technoiogy Lnc.20240—
+6K212491Air Relax Pro Model AR-4.0Diode Art Engineering Doing Business AS Air Relax20210—