Migun

GUDID B344HY7000U0

Migun HY7000U is a multi-function physio therapy table used primarily for pain relief and to increase local circulation. It utilizes thermal far infr

MIGUN LIFE INC

Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: B344HY7000U0
• NIH Device Record Key: 28954fc7-85fe-4c12-9dd2-32a9709c0d27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Migun
• Version Model Number: HY7000U
• Company DUNS: 033919008
• Company Name: MIGUN LIFE INC
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B344HY7000U0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041200

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: 5
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-11

On-Brand Devices [Migun]

• B344MG36000: The Migun Pain Relief Mat provides infra-red heat to different areas of the body. It is indicate
• B344MG33000: The Migun Pain Relief Mat provides infra-red heat to different areas of the body. It is indicate
• B344MG31000: The Migun Pain Relief Mat provides infra-red heat to different areas of the body. It is indicate
• B344HY7770: Far Infra Red photo therapy unit indicated for pain relief and to increase local circulation. It
• B344HY7000UM0: Migun HY7000UM is a multi-function physio therapy table used primarily for pain relief and to i
• B344HY7000U0: Migun HY7000U is a multi-function physio therapy table used primarily for pain relief and to in
• B344ED3010: The Migun Pain Relief Mat provides infra-red heat to different areas of the body. It is indicate