Aroma Season 003

GUDID 06974736970033

An ankle brace with heaitng function powered by a 12V adapter.A controller can control the time and temperature.

Shanghai GK Industrial Co.,Ltd.

Electric pad localized-body heating system

• Primary Device ID: 06974736970033
• NIH Device Record Key: 91023dc9-e81a-452b-a76b-28532766ca50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aroma Season
• Version Model Number: HA-330
• Catalog Number: 003
• Company DUNS: 547295180
• Company Name: Shanghai GK Industrial Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974736970033 [Primary]

FDA Product Code

• IRT: Pad, Heating, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-28
• Device Publish Date: 2024-08-20

On-Brand Devices [Aroma Season]

• 06974736970040: An heating pad with heating function which can wrap around hand. A button can controller the tem
• 06974736970033: An ankle brace with heaitng function powered by a 12V adapter.A controller can control the time
• 06974736970026: An knee brace with heating function powered by a power bank. A controller can control the heatin
• 06974736970019: An eye mask which can heat up with a USB cable.A controller can control the heating time and tem
• 06974736970002: This is a device intended to placed over closed eyes to apply heat for the treatment of meibomia