FDA product code NHH: Device, Discharge, Electrostatic (For Pain Relief)
NHH is the FDA product code for device, discharge, electrostatic (for pain relief). It is a Class II device, regulated under 21 CFR 890.5500 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under NHH, from 2 different applicants. The average 510(k) review took 174 days (median 174).
Definition
An electrostatic discharge device which applies an electrostatic or coronal discharge to or near a person's skin for the symptomatic relief of pain
Classification
| Field | Value |
|---|---|
| Device name | Device, Discharge, Electrostatic (For Pain Relief) |
| Device class | Class II |
| Regulation | 21 CFR 890.5500 |
| Review panel | NE — Neurology |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NHH clearance
Top NHH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Energex Systems, Inc. | 1 | 2005-06-16 |
| Orthosonix, Inc. | 1 | 2001-12-14 |
Most recent NHH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042686 | Energex Systems, Inc. | ENERGEX | 2005-06-16 | 260 |
| K013094 | Orthosonix, Inc. | ORTHOSONIX ENERGEX | 2001-12-14 | 88 |
Recalls for NHH devices
openFDA lists no recalls for product code NHH.
Frequently asked questions
What is FDA product code NHH?
NHH is the FDA product code for device, discharge, electrostatic (for pain relief). It is a Class II device, regulated under 21 CFR 890.5500 and reviewed by the Neurology panel.
What device class is NHH?
Class II, regulation 21 CFR 890.5500. Typical premarket route: 510(k).
How long does a 510(k) take for product code NHH?
Across 2 cleared submissions the average was 174 days from receipt to decision (median 174).
Which companies have the most NHH clearances?
Energex Systems, Inc. (1); Orthosonix, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NHH
- Run a recall and safety report across every NHH manufacturer
- Watch product code NHH 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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