Sanuwave, Inc.: FDA clearances and approvals
Sanuwave, Inc. has 0 FDA 510(k) clearances, plus 1 PMA and 1 De Novo decisions, across 2 product codes in 2 review panels. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBN | Generator, Shock-Wave, For Pain Relief | 1 | 0 |
| PZL | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN160037 | De Novo | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | 2017-12-28 |
| P990086 | PMA | HEALTHTRONICS OSSATRON | 2000-10-12 |
Recalls
openFDA lists no recalls under a recalling firm named Sanuwave, 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.
Device clinical trials
Sanuwave, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00536744: Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers (Completed, started 2007-10)
Frequently asked questions
How many FDA 510(k) clearances does Sanuwave, Inc. have?
Sanuwave, Inc. has 0 FDA 510(k) clearances, plus 1 PMA and 1 De Novo decisions, across 2 product codes in 2 review panels.
What devices does Sanuwave, Inc. make?
Its most frequent FDA product codes are NBN (Generator, Shock-Wave, For Pain Relief, 1); PZL (Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers, 1).
Has Sanuwave, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sanuwave, Inc. Related entities may recall under other names.
Next steps
- See all 0 Sanuwave, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NBN, Sanuwave, 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.