FDA.reportPublic FDA data

Family Wellness

Primary DI
00032251114984
Brand
Family Wellness
Company
Family Dollar Stores
Model
0900543
Device description
Heat Therapy Patch Neck, Shoulder & Small Body Areas
Published
2020-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00032251114984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00032251114984000322511149840322511149840032251114984

GMDN Terms#

Term, Definition table
TermDefinition
Exothermic heat therapy pack/patchA device intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain. It includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated; it may be available in a variety of forms (e.g., adhesive patch, belt containing packs). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117310689
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
00032251578113Family Wellness099901086-9142020-01-27
00032251689659FAMILY WELLNESSSKU9037562025-08-01
00032251689666FAMILY WELLNESSSKU9395042025-08-01
00032251689888FAMILY WELLNESSSKU9976692025-08-01
20032251689653FAMILY WELLNESSSKU9397562025-08-01
10032251689663FAMILY WELLNESSSKU9395042025-08-01
10032251689885FAMILY WELLNESSSKU9976692025-08-01
00032251627620Family Wellness9160612020-08-07
00032251627910Family Wellness9995772020-07-09
00032251921612Family Wellness99957786-359FD2023-10-06
00032251921629Family Wellness91606186-3522023-10-06
00032251057489Family Wellness03225105748909088262020-02-28
00032251057502Family Wellness03225105750209088282020-02-28
00032251057847Family Wellness03225105784709032212020-02-28
00032251058158Family Wellness03225105815809108672020-02-28
00032251911798Family Wellness9028072024-07-08
00032251911804Family Wellness9028062024-07-08
00032251911842Family Wellness9398562024-07-08
00032251911859Family Wellness9996002024-07-08
00032251911866Family Wellness9999862024-07-08

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
00681131403900EQUATEWAL-MART STORES, INC.OMW2024-05-20
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