Wr Medical Electronics Co.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Wr Medical Electronics Co.” (first 1990, latest 2010), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 172 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ETN | Stimulator, Nerve | 2 | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| EGJ | Device, Iontophoresis, Other Uses | 1 | 1 |
| KTB | Device, Iontophoresis, Specific Uses | 1 | 1 |
| LLN | Device, Vibration Threshold Measurement | 1 | 1 |
Review panels
- Ear, Nose and Throat (2)
- Physical Medicine (2)
- Cardiovascular (1)
- Neurology (1)
Most recent Wr Medical Electronics Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092809 | HRV ACQUIRE | DRT | 2010-10-19 | 403 |
| K063560 | HILGER DUAL-STIM NERVE STIMULATOR | ETN | 2007-01-05 | 38 |
| K000574 | IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) | EGJ | 2000-08-09 | 169 |
| K992874 | Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM | KTB | 1999-11-18 | 84 |
| K910624 | CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 | LLN | 1992-01-17 | 339 |
| K895838 | BRACKMANN EMG MONITORING SYSTEM | ETN | 1990-03-27 | 176 |
Recalls
openFDA lists no recalls under a recalling firm named Wr Medical Electronics Co..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Wr Medical Electronics Co.?
FDA lists 6 510(k) clearances under the applicant name “Wr Medical Electronics Co.” (first 1990, latest 2010), across 5 product codes in 4 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 Wr Medical Electronics Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wr Medical Electronics Co. is 172 days.
Which FDA product codes appear under Wr Medical Electronics Co.?
The most frequent FDA product codes under this applicant name are ETN (Stimulator, Nerve, 2); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 1); EGJ (Device, Iontophoresis, Other Uses, 1).
Next steps
- See all 6 Wr Medical Electronics Co. clearances with predicates and recalls
- Run predicate analysis for product code ETN, Wr Medical Electronics Co.'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.