FDA.reportPublic FDA data

Performance Health

Primary DI
00885914087992
Brand
Performance Health
Company
Performance Health Supply, LLC
Model
081213313
Device description
"Digital Moist Heating Pad - Large, 14""x27"""
Published
2024-09-20
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
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885914087999PackageGS11In Commercial Distribution
00885914087992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088591408799910885914087999
00885914087992008859140879928859140879920885914087992

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.

Regulatory Flags#

DUNS number
966806150
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885914040461Rolyan0813016392026-03-20
00885914040478Rolyan081301647N/A2026-03-20
00885914040485Rolyan081301654N/A2026-03-20
00885914004050METRON3030013030012016-09-16
00885914022023METRON9220999220992016-09-16
10885914075927METRON5687825687822017-01-31
10885914077440Performa0817107550817107552017-10-12
00885914077436Performa0817107480817107482017-10-13
00885914107898Sammons Preston70338453821302026-01-23
00885914107966Sammons Preston70338523821372026-01-23
00885914107973Sammons Preston70338533821382026-01-23
00885914107980Sammons Preston70338543821392026-01-23
00885914107997Sammons Preston70338553821402026-01-23
00885914108000Sammons Preston70338563821412026-01-23
00885914108017Sammons Preston70338573821422026-01-23
00885914108024Sammons Preston70338583821432026-01-23
00885914108031Sammons Preston70338593821442026-01-23
00885914108048Sammons Preston70338603821452026-01-23
00885914108055Sammons Preston70338613821462026-01-23
00885914108062Sammons Preston 70338623821472026-01-23

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00622356704953Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356710664Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356710718Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356712200Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356736633Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00840295411637TherabodyTherabody, Inc.IRT2026-06-01
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