PREMIO 10 MOXA 111237

GUDID 03760262493107

The PREMIO 10 – Moxa is a medical device for heat therapy. It consists of the following: • A handpiece with a Power Supply (110-240V~ /50-60Hz) • A tip concentrator • An user manual • A cover of arrangement The PREMIO 10 - MOXA is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 - MOXA is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

SEDATELEC

Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 03760262493107
• NIH Device Record Key: 5abe9e55-6514-435d-9c48-f65a4ed97445
• Commercial Distribution Discontinuation: 2016-09-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PREMIO 10 MOXA
• Version Model Number: PREMIO 10
• Catalog Number: 111237
• Company DUNS: 266031462
• Company Name: SEDATELEC
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 1 KiloPascal and 2 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 1 KiloPascal and 2 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 1 KiloPascal and 2 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 1 KiloPascal and 2 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 1 KiloPascal and 2 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 1 KiloPascal and 2 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 1 KiloPascal and 2 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 1 KiloPascal and 2 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 1 KiloPascal and 2 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 1 KiloPascal and 2 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 1 KiloPascal and 2 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 1 KiloPascal and 2 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 1 KiloPascal and 2 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 1 KiloPascal and 2 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760262493107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101267

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: 2025-04-18
• Device Publish Date: 2016-09-22

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