FDA.reportPublic FDA data

Pain Cakes

Primary DI
00037646700018
Brand
Pain Cakes
Company
Drive Devilbiss Healthcare
Model
TMF70001
Device description
Pain Cakes Large - Blue
Published
2023-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
30037646700019PackageGS112In Commercial Distribution
00037646700018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3003764670001930037646700019
00037646700018000376467000180376467000180037646700018

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.

Contacts#

Phone, Email table
PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00023601061102Carex Health BrandsFGR11000 00002016-10-07
00092237614419Roscoe MedicalHUM-ROS62018-12-19
50050428250391DRIVEMEDICAL7417372019-06-21
00311917192352Walgreens9847282019-06-21
00822383989815DRIVEMEDICAL146-RTLPC23201-M2019-06-21
00822383989839DRIVEMEDICAL146-RTLPC23201-F2019-06-21
00822383246420DriveRTLPC23201-F2017-05-19
00822383037127Silver SportBIN-SSP316DDA-SF2026-06-22
00822383037134Silver SportBIN-SSP218DDA-SF2026-06-22
00822383037141Silver SportBIN-SSP220DDA-SF2026-06-22
00822383037158Cruiser 3 16"BIN-K316ADDA-SF2026-06-22
00822383037165Cruiser 3 18"BIN-K318ADDA-SF2026-06-22
00822383037172Cruiser 3 20"BIN-K320ADDA-SF2026-06-22
00194346283439EquateEQKW5002026-06-10
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00850087597050Recovery+ Go Wrist Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597067Recovery+ Go Ankle Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597074Recovery+ Go Hip Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-23
00850087597012Recovery+ Go Knee Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-17
00850087597005Recovery+ Go Lumbar Thermal Compression WrapWMI ENTERPRISES, LLCIME2026-07-13
00049696508339THERA PlusFOURSTAR GROUP INC.IME2026-06-09
00049696508346B.PUREFOURSTAR GROUP INC.IME2026-06-09
00050428299838CVSHealthFOURSTAR GROUP INC.IME2026-06-09
00840295411637TherabodyTherabody, Inc.IME2026-06-01
00810178885954Arctic FlexVIVE HEALTH LLCIME2026-05-06
307073870439893M™3M COMPANYIME2026-04-21
307073870439963M™3M COMPANYIME2026-04-21
10735282287845MunchkinMUNCHKIN, INC.IME2026-03-18