Electronic Waveform Laboratory, Inc.: FDA clearances and approvals
Electronic Waveform Laboratory, Inc. has 6 FDA 510(k) clearances (first 1982, latest 2011), across 5 product codes in 3 review panels. Median 510(k) review time: 196 days.
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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| KZM | Device, Muscle Monitoring | 1 | 1 |
| LWM | Device, Electrical Dental Anesthesia | 1 | 1 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 | 1 |
Review panels
- Physical Medicine (3)
- Dental (2)
- Neurology (1)
Most recent Electronic Waveform Laboratory, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103738 | H-WAVE | IPF | 2011-06-01 | 161 |
| K081998 | H-WAVE SPORT | NGX | 2009-07-09 | 360 |
| K915230 | H WAVE MUSCLE STIMULATOR | IPF | 1992-05-08 | 170 |
| K873604 | E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY | LWM | 1988-04-12 | 221 |
| K862121 | E.W.L. P-TENS/H-WAVE | KZM | 1987-06-17 | 379 |
| K813601 | E.W.L. P-TENS MODEL(TENS | GZJ | 1982-03-19 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Electronic Waveform Laboratory, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Electronic Waveform Laboratory, Inc. have?
Electronic Waveform Laboratory, Inc. has 6 FDA 510(k) clearances (first 1982, latest 2011), across 5 product codes in 3 review panels.
How long does FDA take to clear Electronic Waveform Laboratory, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Electronic Waveform Laboratory, Inc.'s cleared 510(k)s is 196 days.
What devices does Electronic Waveform Laboratory, Inc. make?
Its most frequent FDA product codes are IPF (Stimulator, Muscle, Powered, 2); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 1); KZM (Device, Muscle Monitoring, 1).
Has Electronic Waveform Laboratory, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Electronic Waveform Laboratory, Inc. Related entities may recall under other names.
Next steps
- See all 6 Electronic Waveform Laboratory, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Electronic Waveform Laboratory, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.