FDA.reportPublic FDA data

Hot/cold therapy pack, reusable

Definition
A non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a reusable device.
GUDID devices
503
Last updated
2025-12-15 16:49:43

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810113579993Arctic Flex VIVE HEALTH LLCRHB3048BLK2025-12-05
00810178880126Arctic FlexVIVE HEALTH LLCRHB3047BLK2025-12-05
00810178880331Arctic FlexVIVE HEALTH LLCRHB3049BLU2025-12-05
10810178884732ViveVIVE HEALTH LLCCSH1109BLU2025-12-05
00810113683577ManaEZ Ice Long Duration KneeManamed, Inc.EZLDIP-KN2025-11-25
00810113683584ManaEZ Ice Long Duration HipManamed, Inc.EZLDIP-HIP2025-11-25
00810113683591ManaEZ Ice Long Duration AnkleManamed, Inc.EZLDIP-ANK2025-11-25
00810113683607ManaEZ Ice Long Duration ShoulderManamed, Inc.EZLDIP-SHLD2025-11-25
00810113683621ManaEZ Ice Long Duration BackManamed, Inc.EZLDIP-BK2025-11-25
00810113683638Cold Compression Wrap, Pro-Ankle WrapManamed, Inc.CCW-PAW2025-09-26
00810113683645Cold Compression Wrap, Pro-Back WrapManamed, Inc.CCW-PBW2025-09-26
00810113683652Cold Compression Wrap, Pro-Elbow WrapManamed, Inc.CCW-PEW2025-09-26
00810113683669Cold Compression Wrap, Pro-Hip WrapManamed, Inc.CCW-PHW2025-09-26
00810113683676Cold Compression Wrap, Pro-Knee WrapManamed, Inc.CCW-PKW2025-09-26
00810113683683Cold Compression Wrap, Pro-Shoulder WrapManamed, Inc.CCW-PSW2025-09-26
00810113683706Cold Compression Wrap, Pro-Ankle Wrap-WLManamed, Inc.4011012025-09-26
00810113683713Cold Compression Wrap, Pro-Shoulder Wrap-WLManamed, Inc.4011032025-09-26
00810113683720Cold Compression Wrap, Pro-Knee Wrap-WLManamed, Inc.4011052025-09-26
00810113683737Cold Compression Wrap, Pro-Hip Wrap-WLManamed, Inc.4011082025-09-26
00810113683744Cold Compression Wrap, Pro-Back Wrap-WLManamed, Inc.4011102025-09-26
06975803355012THERMA ZONEShanghai Youwen Medical Technology Co.,Ltd.003-302022-12-09
06975551433154Hot PackJiangsu Yishun Medical Equipment Co., Ltd.YS-NSD502025-08-28
00810113578712Arctic FlexVIVE HEALTH LLCRHB3039UNI2025-08-25
00810113578811Arctic FlexVIVE HEALTH LLCRHB3038UNI2025-08-25
00810113579962Arctic FlexVIVE HEALTH LLCRHB3043PUR2025-08-25
00810178880133Arctic FlexVIVE HEALTH LLCRHB3046BLK2025-08-25
00850073571125American Hospital SupplyAmerican Hospital Supply LLCAHS-ICE-69_CS2025-07-28
00850073571132American Hospital SupplyAmerican Hospital Supply LLCAHS-HCP-RE_PR2025-07-28
00850073571149American Hospital SupplyAmerican Hospital Supply LLCAHS-HCP-RE_CS2025-07-28
00850073571095American Hospital SupplyAmerican Hospital Supply LLCAHS-HCP-RE_EA2025-07-10
00850073571071American Hospital SupplyAmerican Hospital Supply LLCAHS-ICE-69_EA2025-07-09
00191653900028Belly BanditThe Ergo Baby Carrier Inc.900022024-10-07
00840397517961Sharper ImageMerchsource, LLC10198522025-06-06
30627394040019Pain CakesCOMPASS HEALTH BRANDS CORP.TMF70001CA2025-06-03
00831313005396TRAINERS CHOICETrainer's Choice Inc5012025-05-15
06971898342548GuanyinShanghai Guanyin Ice pack Co.,LtdGY-BD012025-04-24
06973713950242BingfanShanghai BingFan Industrial Co., Ltd.JK-59152025-04-22
06973713950310BingfanShanghai BingFan Industrial Co., Ltd.CPP-31562025-04-22
06973713950563BingfanShanghai BingFan Industrial Co., Ltd.CPP-31562025-04-22
06973713950853BingfanShanghai BingFan Industrial Co., Ltd.1655002025-04-22
06973713950976BingfanShanghai BingFan Industrial Co., Ltd.JK-59212025-04-22
06973713951027BingfanShanghai BingFan Industrial Co., Ltd.JK-59172025-04-22
06973713951072BingfanShanghai BingFan Industrial Co., Ltd.JK-59132025-04-22
06973713951089BingfanShanghai BingFan Industrial Co., Ltd.JK-59202025-04-22
06973713951171BingfanShanghai BingFan Industrial Co., Ltd.JK-59212025-04-22
06973713951423BingfanShanghai BingFan Industrial Co., Ltd.JK-59212025-04-22
06973713951478BingfanShanghai BingFan Industrial Co., Ltd.JK-59132025-04-22
06973713951515BingfanShanghai BingFan Industrial Co., Ltd.JK-59172025-04-22
06973713951713BingfanShanghai BingFan Industrial Co., Ltd.JK-59172025-04-22
06973713951775BingfanShanghai BingFan Industrial Co., Ltd.JK-59182025-04-22
06973713951829BingfanShanghai BingFan Industrial Co., Ltd.JK-59132025-04-22
06973713952116BingfanShanghai BingFan Industrial Co., Ltd.JK-59132025-04-22
06973713952628BingfanShanghai BingFan Industrial Co., Ltd.JK-59182025-04-22
06973713952673BingfanShanghai BingFan Industrial Co., Ltd.JK-59212025-04-22
06973713952888BingfanShanghai BingFan Industrial Co., Ltd.JK-59182025-04-22
06973713952932BingfanShanghai BingFan Industrial Co., Ltd.JK-59172025-04-22
06973713953021BingfanShanghai BingFan Industrial Co., Ltd.JK-59182025-04-22
06973713953069BingfanShanghai BingFan Industrial Co., Ltd.JK-59132025-04-22
06973713953168BingfanShanghai BingFan Industrial Co., Ltd.JK-59202025-04-22
06973713953311BingfanShanghai BingFan Industrial Co., Ltd.1655002025-04-22
06973713953595BingfanShanghai BingFan Industrial Co., Ltd.JK-59212025-04-22
06973713953946BingfanShanghai BingFan Industrial Co., Ltd.JK-59202025-04-22
06973713953984BingfanShanghai BingFan Industrial Co., Ltd.JK-59202025-04-22
06973713954042BingfanShanghai BingFan Industrial Co., Ltd.JK-59202025-04-22
06973713954141BingfanShanghai BingFan Industrial Co., Ltd.JK-59152025-04-22
06973713954356BingfanShanghai BingFan Industrial Co., Ltd.1655002025-04-22
06973713954424BingfanShanghai BingFan Industrial Co., Ltd.JK-59182025-04-22
06973713954714BingfanShanghai BingFan Industrial Co., Ltd.1655002025-04-22
06973713954820BingfanShanghai BingFan Industrial Co., Ltd.JK-59172025-04-22
06973713954936BingfanShanghai BingFan Industrial Co., Ltd.JK-59182025-04-22
06973713954967BingfanShanghai BingFan Industrial Co., Ltd.JK-59182025-04-22
06973713955063BingfanShanghai BingFan Industrial Co., Ltd.JK-59172025-04-22
06973713955285BingfanShanghai BingFan Industrial Co., Ltd.CPP-31562025-04-22
06973713955681BingfanShanghai BingFan Industrial Co., Ltd.JK-59212025-04-22
06973713955698BingfanShanghai BingFan Industrial Co., Ltd.JK-59132025-04-22
06973713955957BingfanShanghai BingFan Industrial Co., Ltd.JK-59212025-04-22
06973713956039BingfanShanghai BingFan Industrial Co., Ltd.JK-59202025-04-22
06973713956312BingfanShanghai BingFan Industrial Co., Ltd.CPP-31562025-04-22
06973713956497BingfanShanghai BingFan Industrial Co., Ltd.JK-59202025-04-22
06973713956541BingfanShanghai BingFan Industrial Co., Ltd.JK-59212025-04-22