TheraBite Range of Motion Scale SC001

GUDID 07331791016622

The Range of Motion Scale is used to monitor the progress of the jaw motion rehabilitation program. The TheraBite Jaw Motion Rehabilitation System is indicated for individuals who have, or are at risk of developing trismus, (restrictions in their ability to open their jaw), and/or experience pain in the joints and/or muscles of the jaw. The device can also be used as a rehabilitation tool for postoperative physical therapy of the jaw, or to maintain the mouth open in a stable position, for example while performing dysphagia exercises.

Atos Medical AB

Mastication muscle exerciser

• Primary Device ID: 07331791016622
• NIH Device Record Key: 5c2ccb90-fd1c-4c4d-81d9-992b1a15d139
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraBite Range of Motion Scale
• Version Model Number: SC001
• Catalog Number: SC001
• Company DUNS: 355470923
• Company Name: Atos Medical AB
• Device Count: 150
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791004865 [Primary]
GS1	07331791016622 [Unit of Use]

FDA Product Code

• ION: Exerciser, Non-Measuring

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: 2022-12-07
• Device Publish Date: 2022-11-29

Devices Manufactured by Atos Medical AB

• 07331791016905 - Provox Adhesive OptiDerm Round: 2024-11-29 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
• 07331791016929 - Provox XtraBase Adhesive: 2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
• 07331791016899 - Provox Adhesive FlexiDerm Plus: 2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
• 07331791016912 - Provox Adhesive OptiDerm Plus: 2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
• 07331791016943 - Provox Life Go HME: 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
• 07331791016950 - Provox Life Home HME: 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
• 07331791016967 - Provox Life Energy HME: 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
• 07331791016974 - Provox Life Protect HME: 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.