Emsi: FDA filings under this applicant name
FDA lists 7 510(k) clearances under 2 spellings of the applicant name “Emsi” (first 2008, latest 2022), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 118 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 | 1 | 225 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 108 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Emsi took a median 108 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 3 | 3 |
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| GXY | Electrode, Cutaneous | 1 | 1 |
Review panels
- Neurology (4)
- Physical Medicine (3)
Most recent Emsi 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221958 | Flex-MI | IPF | 2022-10-21 | 108 |
| K140467 | FLEX-MT + | IPF | 2014-10-07 | 225 |
| K102202 | GS 3000 | IPF | 2010-11-23 | 111 |
| K090889 | EMSI GARMENT ELECTRODES | GXY | 2009-12-04 | 248 |
| K090717 | FLEX-TENS | GZJ | 2009-05-08 | 51 |
| K083030 | TENS-EMS-14 | GZJ | 2009-02-05 | 118 |
| K071869 | TENS/IF 14 | GZJ | 2008-03-07 | 245 |
Recalls
openFDA lists no recalls under a recalling firm named Emsi.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Emsi (6)
- Emsi, Inc. (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Emsi?
FDA lists 7 510(k) clearances under 2 spellings of the applicant name “Emsi” (first 2008, latest 2022), across 3 product codes in 2 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 Emsi?
The median time from FDA receipt to decision across 510(k)s cleared under the name Emsi is 118 days.
Which FDA product codes appear under Emsi?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 3); IPF (Stimulator, Muscle, Powered, 3); GXY (Electrode, Cutaneous, 1).
Next steps
- See all 7 Emsi clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Emsi'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.