Identity
- Trade Name
- TheraBite ActiveBand Kit FDA UDI
- Generic Name
- Mastication muscle exerciser FDA UDI
- Device Name
- The TheraBite ActiveBand is an elastic silicone band used together with the TheraBite Jaw Mobilizer to increase and/or maintain muscle strength and endurance of the muscles of mastication (chewing muscles). The TheraBite ActiveBand is intended for single-patient use only. FDA UDI
- Model / Reference
- 8260 FDA UDI
- Description
- The TheraBite ActiveBand is an elastic silicone band used together with the TheraBite Jaw Mobilizer to increase and/or maintain muscle strength and endurance of the muscles of mastication (chewing muscles). The TheraBite ActiveBand is intended for single-patient use only. FDA UDI
Identifiers
- Catalog Number
- 8260 FDA UDI
- Primary DI / UDI-DI
- 07331791004827 FDA UDI
- FDA Product Code
- ION FDA UDI
- GMDN Term
- Mastication muscle exerciser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Mastication muscle exerciser
TheraBite ActiveBand Kit by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (1)
- FDA UDI 08b3e4a0-ba36-4c27-a6bf-4dc46b43f3ae 36 fields · synced May 30, 2026