Stimulation Technology, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Stimulation Technology, Inc.” (first 1977, latest 1979), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 18 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXY | Electrode, Cutaneous | 3 | 3 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 | 2 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Review panels
- Neurology (5)
- Physical Medicine (1)
Most recent Stimulation Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K791048 | STIMTECH NEUROMUSCULAR STIMULATOR, C 600 | IPF | 1979-07-03 | 27 |
| K790345 | STIMTECH TENS ELECTRODE | GXY | 1979-03-21 | 28 |
| K781565 | ELECTRICAL NERVE STIMULATOR MODEL 6035 | GZJ | 1978-10-11 | 28 |
| K772224 | NERVE STIMULATOR, ELEC. TRANSCUTANEOUS | GZJ | 1977-12-15 | 10 |
| K770448 | INS - T.E.N.S. | GXY | 1977-03-15 | 7 |
| K770447 | EPC INSTICKS | GXY | 1977-03-15 | 7 |
Recalls
openFDA lists no recalls under a recalling firm named Stimulation Technology, Inc..
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 Stimulation Technology, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Stimulation Technology, Inc.” (first 1977, latest 1979), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Stimulation Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stimulation Technology, Inc. is 18 days.
Which FDA product codes appear under Stimulation Technology, Inc.?
The most frequent FDA product codes under this applicant name are GXY (Electrode, Cutaneous, 3); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 2); IPF (Stimulator, Muscle, Powered, 1).
Next steps
- See all 6 Stimulation Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GXY, Stimulation Technology, Inc.'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.