Identity
- Trade Name
- IOPI® FDA UDI
- Generic Name
- Dynamometer force gauge FDA UDI
- Device Name
- IOPI® Report Generator software is an accessory approved for use with the IOPI® Model 3.1 (Pro) and/or the Model 3.2 (Trainer), which are medical devices that measure, evaluate, and increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. This software provides healthcare professionals with a report of device usage to allow them to document and analyze patient progress and usage. This software is intended for clinical use only. FDA UDI
- Model / Reference
- Report Generator v 1.0 FDA UDI
- Description
- IOPI® Report Generator software is an accessory approved for use with the IOPI® Model 3.1 (Pro) and/or the Model 3.2 (Trainer), which are medical devices that measure, evaluate, and increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. This software provides healthcare professionals with a report of device usage to allow them to document and analyze patient progress and usage. This software is intended for clinical use only. FDA UDI
Identifiers
- Catalog Number
- 5-8101 FDA UDI
- Primary DI / UDI-DI
- 10810091040055 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dynamometer force gauge
Iopi® by IOPI Medical LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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- IOPI® — IOPI Medical LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- IOPI Medical LLC
Sources (2)
- FDA UDI d3e433fd-7db0-4a7d-9768-734a4c7fb130 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026