FDA.reportPublic FDA data

Musculoskeletal hot/cold therapy pack, reusable

Definition
A non-powered 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, nor is it designed to be dedicated to eye thermal therapy. This is a reusable device.
GUDID devices
253
Last updated
2026-08-12 10:12:13

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00057475281908BIOS LivingThermor LtdLH1902023-12-08
00057475281915BIOS LivingThermor LtdLH1912023-12-08
00057475281922BIOS LivingThermor LtdLH1922023-12-08
00057475281939BIOS LivingThermor LtdLH1932023-12-08
00057475281946BIOS LivingThermor LtdLH1942024-08-19
00057475282707BIOS LivingThermor LtdLH2702024-03-21
00057475282714BIOS LivingThermor LtdLH2712024-03-21
00057475282721BIOS LivingThermor LtdLH2722024-03-21
00057475283001BIOS LivingThermor LtdLH3002024-08-19
00057475285265BIOS LivingThermor LtdLH5262023-12-08
00057475630010BIOS LivingThermor LtdPM0012023-12-20
00057475630027BIOS LivingThermor LtdPM0022023-12-20
00049696508339THERA PlusFOURSTAR GROUP INC.64409658V2026-06-09
00049696508346B.PUREFOURSTAR GROUP INC.64409346B2026-06-09
00050428299838CVSHealthFOURSTAR GROUP INC.64408678AB2026-06-09
00072239321294Dr. Brown'sDr. Brown's CompanyHG1032022-11-30
00072239321300Dr. Brown'sDr. Brown's CompanyHG1042022-11-30
00072239323878Dr. Brown'sDr. Brown's CompanyHG1112022-11-30
00072239323885Dr. Brown'sDr. Brown's CompanyHG1122022-11-30
00072239323892Dr. Brown'sDr. Brown's CompanyHG1132022-11-30
00072239324813Dr. Brown'sDr. Brown's CompanyHG0822022-11-30
00031262100207HOMEDICSFKA DISTRIBUTING CO., LLCHP-G42AJ2020-08-31
00032251578113Family WellnessFamily Dollar Stores09990102020-01-27
00037646700018Pain CakesDrive Devilbiss HealthcareTMF700012023-05-30
00050428443941CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATED001917-715-CVSU2016-12-10
000511311924303M™ ACE™ Brand3M Company9060012018-09-25
00053891156219SunbeamJarden Consumer Solutions0538911562192021-02-25
00053891156226SunbeamJarden Consumer Solutions0538911562262021-02-25
00080196778631CuradMEDLINE INDUSTRIES, INC.CUR961R2021-05-14
00197998026133Solventum™Solventum US LLC15702026-02-15
00197998026164Solventum™Solventum US LLC15702026-02-15
00197998026614Solventum™Solventum US LLC15722026-02-15
00627394040018Pain CakesDrive Devilbiss HealthcareTMF70001CA2025-06-03
00630140039679CARDINAL HEALTHCardinal Health 200, LLC702042019-06-06
00630140039693CARDINAL HEALTHCardinal Health 200, LLC806002019-06-06
00630140039709CARDINAL HEALTHCardinal Health 200, LLC80304A2022-06-15
00630140039808CARDINAL HEALTHCardinal Health 200, LLC80204A2019-06-06
00632615031003CAREXDrive Devilbiss HealthcareBBF3100-122024-01-31
00735282213182TheraBurpee Reusable Hot & Cold Gel Packs - 2pkMUNCHKIN, INC.213182021-10-01
00749756672504DeRoyalDEROYAL INDUSTRIES, INC.9378-012021-07-29
00749756672511DeRoyalDEROYAL INDUSTRIES, INC.9378-022021-07-29
00749756677806DeRoyalDEROYAL INDUSTRIES, INC.9378-032021-07-29
00749756969765DeRoyalDEROYAL INDUSTRIES, INC.9372-022021-07-29
00749756998413DeRoyalDEROYAL INDUSTRIES, INC.9371-XLS2021-07-29
00810041980151ViveVIVE HEALTH LLCSUP20222024-08-16
00810041981523ViveVIVE HEALTH LLCRHB1049PAD2023-08-07
00810041986023Arctic FlexVIVE HEALTH LLCRHB1098LRG2023-01-10
00810041986047Arctic FlexVIVE HEALTH LLCRHB1098FCE2023-01-10
00810041986054Arctic FlexVIVE HEALTH LLCRHB1098ELB2023-01-10
00810041986061Arctic FlexVIVE HEALTH LLCRHB1098FHE2023-01-10
00810041986078Arctic FlexVIVE HEALTH LLCRHB1098HEA2023-01-10
00810041986085Arctic FlexVIVE HEALTH LLCRHB1098BCK2023-01-10
00810041986092Arctic FlexVIVE HEALTH LLCRHB1098WRS2023-01-10
00810041987693ARCTIC FLEXVIVE HEALTH LLCRHB2062BLK2024-03-08
00810041987860ViveVIVE HEALTH LLCCSH1083GRY2022-01-19
00810041989413Arctic FlexVIVE HEALTH LLCRHB20692022-03-11
00810041989420Arctic FlexVIVE HEALTH LLCRHB2070GRY2022-07-15
00810041989567Arctic Flex VIVE HEALTH LLCRHB20702022-03-07
00810113570082Arctic FlexVIVE HEALTH LLCRHB2084BLK3XL2022-07-27
00810113570099Arctic FlexVIVE HEALTH LLCRHB2089BLKS2023-07-10
00810113570105Arctic FlexVIVE HEALTH LLCRHB2089BLKM2023-07-10
00810113570112Arctic FlexVIVE HEALTH LLCRHB2089BLKL2023-07-10
00810113570143Arctic FlexVIVE HEALTH LLCRHB2090TAL2022-09-02
00810113570198Arctic FlexVIVE HEALTH LLCRHB2092TAL2023-04-06
00810113570624Arctic FlexVIVE HEALTH LLCRHB2097BLKS2023-07-08
00810113570631Arctic FlexVIVE HEALTH LLCRHB2097BLKM2023-07-08
00810113570648Arctic Flex VIVE HEALTH LLCRHB2097BLKL2023-07-08
00810113570723ViveVIVE HEALTH LLCSUP3017GRY2023-06-15
00810113572130Arctic FlexVIVE HEALTH LLCRHB1013L2023-03-01
00810113572383Arctic FlexVIVE HEALTH LLCRHB2103BLKS2023-08-02
00810113572390Arctic FlexVIVE HEALTH LLCRHB2103BLKM2023-08-02
00810113572406Arctic FlexVIVE HEALTH LLCRHB2103BLKL2023-08-02
00810113573779Arctic FlexVIVE HEALTH LLCSUP2017RPAK2023-10-18
00810113574103Arctic FlexVIVE HEALTH LLCRHB3005BLK2023-09-08
00810113574288Arctic FlexVIVE HEALTH LLCRHB3009BLK2023-11-14
00810113574295Arctic FlexVIVE HEALTH LLCRHB3009BLKXL2023-11-14
00810113574387Arctic FlexVIVE HEALTH LLCRHB3012BLK2023-11-14
00810113574394Arctic Flex VIVE HEALTH LLCRHB3013BLKPAK22024-03-12
00810113575001Arctic FlexVIVE HEALTH LLCRHB3017BLK2024-03-12
00810113575391CyrogridVIVE HEALTH LLCSUP30502024-01-11