M-Hi US

GUDID 08033765391702

The M-Hi US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.

ASA SRL

Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 08033765391702
• NIH Device Record Key: 3bf24fd7-6f10-492f-a8f8-f6d3a06261ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M-Hi US
• Version Model Number: F9000296
• Company DUNS: 429533573
• Company Name: ASA SRL
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033765391702 [Primary]

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

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: 2024-07-09
• Device Publish Date: 2024-07-01

Devices Manufactured by ASA SRL

• 08033765391740 - M-Hi D US: 2024-10-18 The M-Hi D US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treat
• 08033765391702 - M-Hi US: 2024-07-09The M-Hi US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.
• 08033765391702 - M-Hi US: 2024-07-09 The M-Hi US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatme
• 08033765391689 - M7: 2023-11-29 The M7 is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of