FDA.reportPublic FDA data

Sunbeam

Primary DI
30053891162693
Brand
Sunbeam
Company
Jarden Consumer Solutions
Model
053891162692
Device description
Hot/Cold Gel Pack for Knee Brace
Published
2023-04-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IMEPack, Hot Or Cold, Reusable
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30053891162693PackageGS14In Commercial Distribution
00053891162692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3005389116269330053891162693
00053891162692000538911626920538911626920053891162692

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad localized-body heating systemAn assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001315134
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00053891156219Sunbeam0538911562192021-02-25
00053891156226Sunbeam0538911562262021-02-25
00053891181952Sunbeam0538911819522025-12-03
00053891177184Sunbeam0538911771842024-09-10
00053891177207Sunbeam0538911772072024-09-10
00053891177221Sunbeam0538911772212024-09-10
00053891177245Sunbeam0538911772452024-09-10
30053891177185Sunbeam0538911771842024-09-10
30053891177208Sunbeam0538911772072024-09-10
30053891177222Sunbeam0538911772212024-09-10
30053891177246Sunbeam0538911772452024-09-10
00053891172073Sunbeam0538911720732023-10-12
30053891172074Sunbeam0538911720732023-10-12
00053891162692Sunbeam0538911626922023-04-12
00053891172066Sunbeam0538911720662023-03-13
30053891172067Sunbeam0538911720662023-03-13
00053891172172Sunbeam0538911721722022-11-15
00053891172189Sunbeam0538911721892022-11-15
00053891174015Sunbeam0538911740152022-11-15
00053891174022Sunbeam0538911740222022-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050289252HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289269HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289276HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289283HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289290HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289306HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
03858894530069Thigh Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530083Knee/Calf Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530106Lumbar Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530120Shoulder Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530144Elbow/Wrist Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530168Anatomic Ankle Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530205Anatomic Knee Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530243Hip Thermic Wrap RightZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530267Hip Thermic Wrap LeftZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530274Jaw Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894530281Face Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
03858894531257Full Leg Thermic Wrap RightZAMAR MEDICAL d.o.o.IME2026-10-12
03858894531264Full Leg Thermic Wrap LeftZAMAR MEDICAL d.o.o.IME2026-10-12
03858894531271Anatomic Knee/Thigh Thermic WrapZAMAR MEDICAL d.o.o.IME2026-10-12
00622356753760Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00622356753937Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00622356759533Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00040337006559ThermophoreBattle Creek Equipment Co.IRT2026-08-07
088095244977693H Heating Belt3H, Co., LtdIRT2026-07-29
088095244977763H Abdomen Fomentation Device3H, Co., LtdIRT2026-07-29
088095244977833H Abdomen Fomentation Device3H, Co., LtdIRT2026-07-29
00850087597029Recovery+ Go Right Shoulder Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597036Recovery+ Go Left Shoulder Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597043Recovery+ Go Cervical Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23