HWATO TDP Heat Lamp

GUDID 06901452000003

HWATO TDP Heat Lamp is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, t

Suzhou Medical Appliance Factory

Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 06901452000003
• NIH Device Record Key: 5dbac94b-3017-4a84-a146-be0759b1264d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HWATO TDP Heat Lamp
• Version Model Number: TDP11-DL
• Company DUNS: 653739474
• Company Name: Suzhou Medical Appliance Factory
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Weight: 9 Kilogram

Device Identifiers

Device Issuing Agency	Device ID
GS1	06901452000003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063568

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-05

On-Brand Devices [HWATO TDP Heat Lamp]

• 06901452000058: HWATO TDP Heat Lamp is an infrared lamp that emits the infrared spectrum to provide topical heat
• 06901452000010: HWATO TDP Heat Lamp is an infrared lamp that emits the infrared spectrum to provide topical heat
• 06901452000003: HWATO TDP Heat Lamp is an infrared lamp that emits the infrared spectrum to provide topical heat