DEVICE: TheraBite Jaw Motion Rehabilitation System, Adult (07331791004872)
Device Identifier (DI) Information
TheraBite Jaw Motion Rehabilitation System, Adult
TH001
In Commercial Distribution
TH001
Atos Medical AB
TH001
In Commercial Distribution
TH001
Atos Medical AB
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.
The TheraBite system is intended for single-patient use only
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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17802 | Mastication muscle exerciser |
An intraoral mechanical exercise apparatus intended primarily to strengthen and rehabilitate the jaw muscles of mastication of a patient who has pain in, or disorders of, the temporomandibular joint (TMJ), typically through repetitive biting against resistive forces provided by the device. This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
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ION | Exerciser, Non-Measuring |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep away from rain. Keep away from sunlight. |
Storage Environment Temperature: between 2 and 42 Degrees Celsius |
Storage Environment Temperature: between 36 and 108 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Width: 6 Centimeter |
Device Record Status
2bc879af-cc50-4f3c-9435-3f63708e2d67
November 25, 2024
4
November 28, 2022
November 25, 2024
4
November 28, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4641519800
info@atosmedical.com
info@atosmedical.com