Ecobrands , Ltd.: FDA clearances and approvals
Ecobrands , Ltd. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OSG | Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN100024 | De Novo | Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch | 2014-11-07 |
Recalls
openFDA lists no recalls under a recalling firm named Ecobrands , Ltd..
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.
Device clinical trials
Ecobrands , Ltd. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00822575: Study of a Device to Relieve Mosquito Bite Itching. (Completed, started 2008-04)
Frequently asked questions
How many FDA 510(k) clearances does Ecobrands , Ltd. have?
Ecobrands , Ltd. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Ecobrands , Ltd. make?
Its most frequent FDA product codes are OSG (Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch, 1).
Has Ecobrands , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ecobrands , Ltd. Related entities may recall under other names.
Next steps
- See all 0 Ecobrands , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OSG, Ecobrands , Ltd.'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.