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TheraBite Jaw Motion Rehabilitation System, Adult
EUDAMEDFDA UDIClass I (EU MDR)
Ref TH001
Identity
- Trade Name
- TheraBite Jaw Motion Rehabilitation System, Adult EUDAMEDFDA UDI
- Generic Name
- Mastication muscle exerciser FDA UDI
- Device Name
- TheraBite rehabilitation system EUDAMEDThe 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 FDA UDI
- Model / Reference
- TH001 EUDAMEDFDA UDI
- Description
- 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 FDA UDI
Identifiers
- Catalog Number
- TH001 FDA UDI
- Primary DI / UDI-DI
- 07331791004872 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-JAW-0-000-0000-98 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
No
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
Dimensions & Sizes
- Size
- Width — 6 Centimeter FDA UDI
TheraBite Jaw Motion Rehabilitation System, Adult 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-0-000-0000-98 | 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 7ee0d976-7b25-4b72-bc36-ccf5d2ad3e3f 61 fields · synced Oct 6, 2026
- FDA UDI 2bc879af-cc50-4f3c-9435-3f63708e2d67 37 fields · synced May 30, 2026