Smartmissimo Technologies Pte, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Smartmissimo Technologies Pte, Ltd.” (first 2015, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 123 days. Since 2017 the median was 98 days, against 137 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 |
|---|---|---|
| 2015 | 1 | 258 |
| 2016 | 0 | — |
| 2017 | 1 | 74 |
| 2018 | 1 | 130 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 72 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Smartmissimo Technologies Pte, Ltd. took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | 2 |
Review panels
Most recent Smartmissimo Technologies Pte, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210938 | PowerDot PD-01MT2 Muscle Stimulator | IPF | 2021-07-30 | 123 |
| K210269 | PowerDot PD-01MT2 Muscle Stimulator | IPF | 2021-02-23 | 22 |
| K181759 | PowerDot PD-01MT | IPF | 2018-11-09 | 130 |
| K172876 | PowerDot PD-01M | NGX | 2017-12-04 | 74 |
| K150078 | PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application) | NGX | 2015-09-30 | 258 |
Recalls
openFDA lists no recalls under a recalling firm named Smartmissimo Technologies Pte, Ltd..
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 Smartmissimo Technologies Pte, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Smartmissimo Technologies Pte, Ltd.” (first 2015, latest 2021), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Smartmissimo Technologies Pte, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smartmissimo Technologies Pte, Ltd. is 123 days. Since 2017: 98 days, versus 137 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Smartmissimo Technologies Pte, Ltd.?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 3); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 2).
Next steps
- See all 5 Smartmissimo Technologies Pte, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Smartmissimo Technologies Pte, Ltd.'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.