FDA.reportPublic FDA data

Aroma Season

Primary DI
06974736970026
Brand
Aroma Season
Company
Shanghai GK Industrial Co.,Ltd.
Model
HEB-323
Catalog number
002
Device description
An knee brace with heating function powered by a power bank. A controller can control the heating time and temperature.
Published
2024-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
06974736970026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974736970026069747369700266974736970026

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

Contacts#

Phone, Email table
PhoneEmail
18702115996jango@gkier.com

Regulatory Flags#

DUNS number
547295180
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974736970002Aroma SeasonM12002024-10-10
06974736970019Aroma SeasonAM-HE9200012024-08-20
06974736970033Aroma SeasonHA-3300032024-08-20
06974736970040Aroma SeasonWHP-3400042024-08-20

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