Stimwave Technologies Incorporated: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Stimwave Technologies Incorporated” (first 2014, latest 2019), across 1 product code in 1 review panel. Median 510(k) review time under this name: 136 days. Since 2017 the median was 132 days, against 108 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 |
|---|---|---|
| 2014 | 1 | 135 |
| 2015 | 1 | 95 |
| 2016 | 2 | 156 |
| 2017 | 2 | 84 |
| 2018 | 1 | 159 |
| 2019 | 1 | 182 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 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 Stimwave Technologies Incorporated took a median 132 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 8 | 8 |
Review panels
- Neurology (8)
Most recent Stimwave Technologies Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182720 | Freedom Spinal Cord Stimulator (SCS) System | GZB | 2019-03-29 | 182 |
| K180981 | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit | GZB | 2018-09-19 | 159 |
| K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base | GZB | 2017-11-03 | 63 |
| K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit | GZB | 2017-05-02 | 105 |
| K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit | GZB | 2016-12-16 | 136 |
| K160600 | Freedom Spinal Cord Stimulator System | GZB | 2016-08-26 | 177 |
| K150517 | Freedom Spinal Cord Stimulator System | GZB | 2015-06-05 | 95 |
| K141399 | FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM | GZB | 2014-10-10 | 135 |
Recalls
openFDA lists no recalls under a recalling firm named Stimwave Technologies Incorporated.
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.
- Stimwave Technologies, Inc. (1 510(k)s)
- Stimwave Technologies Inc., Dba Stimq, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stimwave Technologies Incorporated?
FDA lists 8 510(k) clearances under the applicant name “Stimwave Technologies Incorporated” (first 2014, latest 2019), 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 Stimwave Technologies Incorporated?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stimwave Technologies Incorporated is 136 days. Since 2017: 132 days, versus 108 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Stimwave Technologies Incorporated?
The most frequent FDA product codes under this applicant name are GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief), 8).
Next steps
- See all 8 Stimwave Technologies Incorporated clearances with predicates and recalls
- Run predicate analysis for product code GZB, Stimwave Technologies Incorporated'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.