FDA product code NKI: Goniometer With Electrodes
NKI is the FDA product code for goniometer with electrodes. It is a Class II device, regulated under 21 CFR 888.1500 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under NKI. The average 510(k) review took 113 days (median 113).
Definition
A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording range of motion, acceleration, or forces exerted by a joint. The class II (special controls) goniometer uses transcutaneous adhesive electrode lead wires and patient cables to transmit and record patient data.
Classification
| Field | Value |
|---|---|
| Device name | Goniometer With Electrodes |
| Device class | Class II |
| Regulation | 21 CFR 888.1500 |
| Review panel | NE — Neurology |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NKI clearance
Top NKI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Friendly Sensors AG | 1 | 2004-01-23 |
Most recent NKI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K033193 | Friendly Sensors AG | SONOSENS | 2004-01-23 | 113 |
Recalls for NKI devices
openFDA lists no recalls for product code NKI.
Frequently asked questions
What is FDA product code NKI?
NKI is the FDA product code for goniometer with electrodes. It is a Class II device, regulated under 21 CFR 888.1500 and reviewed by the Neurology panel.
What device class is NKI?
Class II, regulation 21 CFR 888.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NKI?
Across 1 cleared submissions the average was 113 days from receipt to decision (median 113).
Which companies have the most NKI clearances?
Friendly Sensors AG (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NKI
- Run a recall and safety report across every NKI manufacturer
- Watch product code NKI 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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