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TheraBite Range of Motion Scale (150 pcs)
EUDAMEDFDA UDIClass I (EU MDR)
Ref SC001
Identity
- Trade Name
- TheraBite Range of Motion Scale (150 pcs) EUDAMEDFDA UDI
- Generic Name
- Mastication muscle exerciser FDA UDI
- Device Name
- TheraBite scale EUDAMEDThe 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. FDA UDI
- Model / Reference
- SC001 EUDAMEDFDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- SC001 FDA UDI
- Primary DI / UDI-DI
- 07331791004865 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-JAW-A-000-0002-QW EUDAMED
- Unit of Use DI
- 07331791016622 EUDAMED
- FDA Product Code
- ION FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Mastication muscle exerciser FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5370 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
TheraBite Range of Motion Scale (150 pcs) by Atos Medical AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7331791-JAW-A-000-0002-QW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical AB
- EUDAMED SRN
- SE-MF-000000725
Sources (2)
- EUDAMED dcd36d8a-2e8d-4e84-9242-66085699e52d 61 fields · synced Oct 7, 2026
- FDA UDI 5c2ccb90-fd1c-4c4d-81d9-992b1a15d139 36 fields · synced May 30, 2026