FDA.reportPublic FDA data

RENPHO heating pad

Primary DI
26971912180013
Brand
RENPHO heating pad
Company
NINGBO BELLA VIE CO., LTD
Model
NA-H1821B
Published
2021-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
26971912180013PackageGS112In Commercial Distribution
16971912180016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2697191218001326971912180013
1697191218001616971912180016

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy systemAn electrically-powered assembly of devices intended to apply controlled heat and cold therapy (including contrast therapy) to the surface of the body for a variety of physiotherapy applications such as treatment of musculoskeletal pain, inflammation reduction, and analgesia during intramuscular injection. It includes both a control unit and a handpiece with a heating/cooling endpiece; liquid coolant is used to provide the cooling effect.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
561007300
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
16971912180030Walgreens heating padNA-H40BN2021-05-11
26971912180037Walgreens heating padNA-H40BN2021-05-11
16971912180016RENPHO heating padNA-H1821B2021-03-31
16971912180023Walgreens heating padNA-H40B2021-03-31
26971912180020Walgreens heating padNA-H40B2021-03-31

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