Identity
- Trade Name
- IOPI® FDA UDI
- Generic Name
- Dynamometer force gauge FDA UDI
- Device Name
- The IOPI® Trainer (Model 3.2) is used to increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. The IOPI® Trainer is intended for clinical use and use by patients outside their therapy sessions under the direction of a healthcare professional. FDA UDI
- Model / Reference
- Model 3.2 FDA UDI
- Description
- The IOPI® Trainer (Model 3.2) is used to increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. The IOPI® Trainer is intended for clinical use and use by patients outside their therapy sessions under the direction of a healthcare professional. FDA UDI
Identifiers
- Catalog Number
- 8-3201 FDA UDI
- Primary DI / UDI-DI
- 10810091040048 FDA UDI
- FDA Product Code
- IKE FDA UDI
- GMDN Term
- Dynamometer force gauge FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.1615 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dynamometer force gauge
Iopi® by IOPI Medical LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- IOPI® — IOPI Medical LLC · Class I
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
- IOPI Medical LLC
Sources (1)
- FDA UDI 875dec1b-8cbe-486a-837b-1ab7d75aa8be 36 fields · synced Jun 8, 2026