FDA product code LIH: Interferential Current Therapy
LIH is the FDA product code for interferential current therapy. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel. FDA has cleared 73 510(k) submissions under LIH, 1 in the last five years, from 50 different applicants. The average 510(k) review took 193 days (median 154); 253 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Interferential Current Therapy |
| Device class | Class II |
| Regulation | 21 CFR 882.5890 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LIH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 163 |
| 2021 | 1 | 190 |
| 2024 | 1 | 253 |
Compare with all 510(k) review times · Search every LIH clearance
Top LIH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dynatronics Corp. | 7 | 2001-05-15 |
| Biomedical Life Systems, Inc. | 5 | 2004-07-07 |
| Excel Tech. , Ltd. | 5 | 1996-03-22 |
| Gemore Technology Co, Ltd. | 2 | 2012-12-21 |
| Fuji Dynamics Limited | 2 | 2010-01-07 |
45 more applicants have LIH clearances. See the full list in Caduvo.
Most recent LIH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231575 | Artaflex, Inc. | Vecttor VT-300 | 2024-02-08 | 253 |
| K202725 | Therasigma, LLC | ETD4000 | 2021-03-26 | 190 |
| K183692 | Vision Quest Industries Inc./Dba VQ Orthocare | Avid IF2 | 2019-06-12 | 163 |
| K122944 | Gemore Technology Co, Ltd. | GEMORE TRUE SINE INTERFERENTIAL STIMULATOR | 2012-12-21 | 88 |
| K121662 | Alan Neuromedical Technologies, LLC | VECTTOR VT-200 | 2012-11-21 | 169 |
Recalls for LIH devices
openFDA lists no recalls for product code LIH.
Frequently asked questions
What is FDA product code LIH?
LIH is the FDA product code for interferential current therapy. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel.
What device class is LIH?
Class II, regulation 21 CFR 882.5890. Typical premarket route: 510(k).
How long does a 510(k) take for product code LIH?
Across 73 cleared submissions the average was 193 days from receipt to decision (median 154).
Which companies have the most LIH clearances?
Dynatronics Corp. (7); Biomedical Life Systems, Inc. (5); Excel Tech. , Ltd. (5); Gemore Technology Co, Ltd. (2); Fuji Dynamics Limited (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LIH
- Run a recall and safety report across every LIH manufacturer
- Watch product code LIH 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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