Identity
- Trade Name
- D function FDA UDI
- Generic Name
- Mastication muscle electrical stimulation system FDA UDI
- Device Name
- Dual Channel Electrical Muscle Stimulator for TMJ Pain Relief FDA UDI
- Model / Reference
- D function FDA UDI
- Description
- Dual Channel Electrical Muscle Stimulator for TMJ Pain Relief FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04983087012394 FDA UDI
- 510(k) Number
- K203525 FDA UDI
- FDA Product Code
- NUW FDA UDI
- GMDN Term
- Mastication muscle electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mastication muscle electrical stimulation system
D function by Ito Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Ito Co., Ltd.
Sources (1)
- FDA UDI e21233af-a22a-4200-8bb9-0cec8844d380 34 fields · synced May 30, 2026