Identity
- Trade Name
- EMA FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- EMA Bite Pads (2 pieces) FDA UDI
- Model / Reference
- EMABP FDA UDI
- Description
- EMA Bite Pads (2 pieces) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842326100404 FDA UDI
- 510(k) Number
- K971794 FDA UDI
- FDA Product Code
- LRK FDA UDI
- GMDN Term
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5570 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mandible-repositioning sleep-disordered breathing orthosis
Ema by The Myerson Company Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mandible-repositioning sleep-disordered breathing orthosis.
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Cleared under the same submission
K971794 also covers:
- EMA — The Myerson Company Limited
- EMA — The Myerson Company Limited
- EMA — The Myerson Company Limited
- EMA — The Myerson Company Limited
- EMA — The Myerson Company Limited
- EMA — The Myerson Company Limited
- EMA — The Myerson Company Limited
- EMA — The Myerson Company Limited
- EMA — The Myerson Company Limited
- EMA — The Myerson Company Limited
- EMA — The Myerson Company Limited
- EMA — The Myerson Company Limited
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 II | Pending data |
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Manufacturer
- Manufacturer
- The Myerson Company Limited
Sources (1)
- FDA UDI 55cd67ad-26fa-4f5c-8971-31e931a04be8 35 fields · synced Jun 8, 2026