Theranica Bioelectronics , Ltd.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Theranica Bioelectronics , Ltd.” (first 2021, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 112 days. Since 2017 the median was 112 days, against 112 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 |
|---|---|---|
| 2021 | 1 | 88 |
| 2022 | 0 | — |
| 2023 | 2 | 115 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Theranica Bioelectronics , Ltd. took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QGT | Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine | 4 | 3 |
Review panels
- Neurology (4)
Most recent Theranica Bioelectronics , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232152 | NerivioInfinity | QGT | 2023-11-08 | 112 |
| K223169 | Nerivio | QGT | 2023-02-06 | 118 |
| K203181 | Nerivio, FGD000075-4.7 | QGT | 2021-01-22 | 88 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180059 | De Novo | Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine | 2019-05-20 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2026-03-23.
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.
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.
- Theranica Bio-Electronics, Ltd. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Theranica Bioelectronics , Ltd.?
FDA lists 3 510(k) clearances under the applicant name “Theranica Bioelectronics , Ltd.” (first 2021, latest 2023), plus 1 De Novo decision, across 1 product code 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 Theranica Bioelectronics , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Theranica Bioelectronics , Ltd. is 112 days. Since 2017: 112 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Theranica Bioelectronics , Ltd.?
The most frequent FDA product codes under this applicant name are QGT (Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine, 4).
Next steps
- See all 3 Theranica Bioelectronics , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QGT, Theranica Bioelectronics , 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.