FDA.reportPublic FDA data

EQUATE

Primary DI
00681131403900
Brand
EQUATE
Company
WAL-MART STORES, INC.
Model
422266
Device description
EQUATE AIR ACTIVATED HEAT WRAP
Published
2024-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
OMWAdhesive Backed Thermal Skin Patches

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMWAdhesive Backed Thermal Skin PatchesPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50681131403905PackageGS13In Commercial Distribution
60681131403902PackageGS112In Commercial Distribution
00681131403900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5068113140390550681131403905
6068113140390260681131403902
00681131403900006811314039006811314039000681131403900

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal hot/cold therapy pack, single-useA 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 single-use device.

Regulatory Flags#

DUNS number
051957769
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00194346693122EquateWAL4545V4WAL4545V42026-06-02
00194346693139EquateWAL4245V4WAL4245V42026-06-02
00681131106108Equate5998092362026-02-25
00681131106092Equate5997602702026-02-25
00194346711994ReliOn1943467119942026-05-20
06974021412637equate sitz bathESB-012025-10-08
06974021412644equate shower benchESH-012025-10-08
00194346404131EquateEM47RP2026-05-08
00681131405898EquateHTD8813CHTD8815US2021-04-21
00194346614028Equate 3 UltraUA-8010BLEWMUA-8010BLEWM2026-05-04
00194346618057Equate 1 ProUA-4010WMUA-4010WM2026-05-04
00194346618064Equate 2 PlusUA-6010BLEWMUA-6010BLEWM2026-05-04
00194346404148EquateUHP252026-05-01
00194346404155EquateEM472026-05-01
00681131161602equate6811311616022025-05-14
00681131286213Equate6811312862132020-03-30
00194346067015EQUATE 682710647; 6587876092023-02-14
00681131116374EQUATE682710649, 6513554052022-10-28
00194346699421EquateFBL7100072026-04-17
00194346219230ReliOn™ Premier Classic Meter784001N/A2025-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00383568101618EZflex Lidocaine 4% pain relief patch 5 countCare Living Diagnostics Inc.OMW2025-11-04
00383568101625EZflex Lidocaine 4% & Menthol 1% pain relief patch 5 countCare Living Diagnostics Inc.OMW2025-11-04
06945397906167Up&UpTARGET CORPORATIONOMW2025-09-05
06945397906174Up&UpTARGET CORPORATIONOMW2025-09-05
06959962439011Pain Relief PatchHunan Jianyuan Medical Science And Technology Co., Ltd.OMW2025-02-28
00840117341043CozyTherm Heat Relief Patches MenstrualDynarex CorporationOMW2025-02-13
00840117341050CozyTherm Heat Relief Wrap, BackDynarex CorporationOMW2025-02-13
00840117341067CozyTherm Heat Relief Patch, NeckDynarex CorporationOMW2025-02-13
00072959010799UricalmAlva/Amco Pharmacal Companies, Inc.OMW2024-12-20
60072959010791UricalmAlva/Amco Pharmacal Companies, Inc.OMW2024-12-20
00072959019747BackAidAlva/Amco Pharmacal Companies, Inc.OMW2024-11-29
50681131403905EQUATEWAL-MART STORES, INC.OMW2024-05-20
06945397906181Up&UpTARGET CORPORATIONOMW2024-02-28
06945397906198Up&UpTARGET CORPORATIONOMW2024-02-28
00057475363055BIOS DiagnosticsThermor LtdOMW2023-12-08
20057475363059BIOS DiagnosticsThermor LtdOMW2023-12-08
00072959015749BackAidAlva/Amco Pharmacal Companies, Inc.OMW2023-05-01
60072959015741BackAidAlva/Amco Pharmacal Companies, Inc.OMW2023-05-01
00049696869737N/AFOURSTAR GROUP INC.OMW2023-02-05
00810084939406FifthPulseJeg & Sons Inc.OMW2022-12-16
00810084939413FifthPulseJeg & Sons Inc.OMW2022-12-16
06974567749631Rhino RescueWuxi Emsrun Technology Co., Ltd.OMW2022-12-08
10850046230223Future Generation Medical Global International L. L. C.OMW2022-11-13
10850046230230Future Generation Medical Global International L. L. C.OMW2022-11-13
30850046230289Future Generation Medical Global International L. L. C.OMW2022-11-13
60850046230297FG-HCP0916Global International L. L. C.OMW2022-11-13
00850046230226Future Generation Medical Global International L. L. C.OMW2022-11-13
00850046230233Future Generation Medical Global International L. L. C.OMW2022-11-13
00850046230288Future Generation Medical Global International L. L. C.OMW2022-11-13
00850046230295FG-HCP0916Global International L. L. C.OMW2022-11-13