FDA product code NTU: Evoked Potential Stimulator, Thermal
NTU is the FDA product code for evoked potential stimulator, thermal. It is a Class II device, regulated under 21 CFR 882.1870 and reviewed by the Neurology panel. FDA has cleared 3 510(k) submissions under NTU. The average 510(k) review took 132 days (median 143).
Definition
Intended to evaluate the functionality of human pain reception and transmission of sensory pathways
Classification
| Field | Value |
|---|---|
| Device name | Evoked Potential Stimulator, Thermal |
| Device class | Class II |
| Regulation | 21 CFR 882.1870 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NTU clearance
Top NTU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medoc Ltd. Advanced Medical Systems | 3 | 2006-01-19 |
Most recent NTU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052357 | Medoc Ltd. Advanced Medical Systems | PATHWAY - ATS/CHEPS | 2006-01-19 | 143 |
| K051448 | Medoc Ltd. Advanced Medical Systems | MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS) | 2005-06-29 | 27 |
| K041908 | Medoc Ltd. Advanced Medical Systems | CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS) | 2005-02-25 | 225 |
Recalls for NTU devices
openFDA lists no recalls for product code NTU.
Frequently asked questions
What is FDA product code NTU?
NTU is the FDA product code for evoked potential stimulator, thermal. It is a Class II device, regulated under 21 CFR 882.1870 and reviewed by the Neurology panel.
What device class is NTU?
Class II, regulation 21 CFR 882.1870. Typical premarket route: 510(k).
How long does a 510(k) take for product code NTU?
Across 3 cleared submissions the average was 132 days from receipt to decision (median 143).
Which companies have the most NTU clearances?
Medoc Ltd. Advanced Medical Systems (3).
Next steps
- Run an FDA pathway report with predicate devices for product code NTU
- Run a recall and safety report across every NTU manufacturer
- Watch product code NTU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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