FDA.reportPublic FDA data

Family Wellness

Primary DI
00032251578113
Brand
Family Wellness
Company
Family Dollar Stores
Model
0999010
Catalog number
86-914
Device description
Family Wellness Hot-Cold Reusable Gel Pack-Direct to Skin, 1 Count
Published
2020-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IMEPack, Hot Or Cold, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10032251578110PackageGS124In Commercial Distribution
30032251578114PackageGS13In Commercial Distribution
00032251578113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003225157811010032251578110
3003225157811430032251578114
00032251578113000322515781130322515781130032251578113

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal hot/cold therapy pack, reusableA 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.

Regulatory Flags#

DUNS number
117310689
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00032251911873Family Wellness9021652024-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840295411637TherabodyTherabody, Inc.IME2026-06-01
00810178885954Arctic FlexVIVE HEALTH LLCIME2026-05-06
00840397513215Sharper ImageMerchsource, LLCIME2026-04-23
307073870439893M™3M COMPANYIME2026-04-21
307073870439963M™3M COMPANYIME2026-04-21
10735282287845MunchkinMUNCHKIN, INC.IME2026-03-18
00197998026133Solventum™Solventum US LLCIME2026-02-15
00197998026164Solventum™Solventum US LLCIME2026-02-15
00197998026614Solventum™Solventum US LLCIME2026-02-15
00810178884735ViveVIVE HEALTH LLCIME2025-12-05
00810113683065ManaEZ ROM Ice ShortManamed, Inc.IME2025-10-17
00810113683515ManaEZ Hip Ice CureTechManamed, Inc.IME2025-10-03
00810113683522ManaEZ ROM Ice CureTechManamed, Inc.IME2025-10-03
00810113683539ManaEZ Shoulder Ice CureTechManamed, Inc.IME2025-10-03
00810113683638Cold Compression Wrap, Pro-Ankle WrapManamed, Inc.IME2025-09-26
00810113683645Cold Compression Wrap, Pro-Back WrapManamed, Inc.IME2025-09-26
00810113683652Cold Compression Wrap, Pro-Elbow WrapManamed, Inc.IME2025-09-26
00810113683669Cold Compression Wrap, Pro-Hip WrapManamed, Inc.IME2025-09-26
00810113683676Cold Compression Wrap, Pro-Knee WrapManamed, Inc.IME2025-09-26
00810113683683Cold Compression Wrap, Pro-Shoulder WrapManamed, Inc.IME2025-09-26
00810113683706Cold Compression Wrap, Pro-Ankle Wrap-WLManamed, Inc.IME2025-09-26
00810113683713Cold Compression Wrap, Pro-Shoulder Wrap-WLManamed, Inc.IME2025-09-26
00810113683720Cold Compression Wrap, Pro-Knee Wrap-WLManamed, Inc.IME2025-09-26
00810113683737Cold Compression Wrap, Pro-Hip Wrap-WLManamed, Inc.IME2025-09-26
00810113683744Cold Compression Wrap, Pro-Back Wrap-WLManamed, Inc.IME2025-09-26
00850073571101American Hospital SupplyAmerican Hospital Supply LLCIME2025-07-28
00850073571118American Hospital SupplyAmerican Hospital Supply LLCIME2025-07-28
00627394040018Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00627394040056Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00627394040063Pain CakesDrive Devilbiss HealthcareIME2025-06-03