Zynex Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Zynex Medical, Inc.” (first 2011, latest 2024), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 138 days. Since 2017 the median was 241 days, against 172 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 64 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 241 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 242 |
| 2024 | 1 | 91 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zynex Medical, Inc. took a median 241 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 172 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | 2 | 2 |
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 | 1 |
Review panels
Most recent Zynex Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233485 | M-Wave | IPF | 2024-01-26 | 91 |
| K223217 | Zynex Monitoring System, Model CM-1600 | DSB | 2023-06-16 | 242 |
| K191697 | Cardiac Monitor 1500 | DSB | 2020-02-21 | 241 |
| K121820 | INWAVE | KPI | 2012-08-24 | 64 |
| K111279 | NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM | IPF | 2011-09-20 | 138 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2009-01-25.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Zynex Medical, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05972889: Randomized Blinded Evaluation of the Effects of TENS and IFC Compared to a Sham Device and SOC in Patients With Non-Specific CLBP (Completed, started 2023-11-02)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Zynex Medical, Inc. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Zynex Medical Officer (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zynex Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Zynex Medical, Inc.” (first 2011, latest 2024), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Zynex Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zynex Medical, Inc. is 138 days. Since 2017: 241 days, versus 172 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zynex Medical, Inc.?
The most frequent FDA product codes under this applicant name are DSB (Plethysmograph, Impedance, 2); IPF (Stimulator, Muscle, Powered, 2); KPI (Stimulator, Electrical, Non-Implantable, For Incontinence, 1).
Next steps
- See all 5 Zynex Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSB, Zynex Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.