Uni-Patch, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Uni-Patch, Inc.” (first 1987, latest 1999), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 62 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 |
| GYB | Media, Electroconductive | 1 | 1 |
Review panels
- Neurology (6)
Most recent Uni-Patch, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983097 | TENS/FES/NMES ELECTRODES | GXY | 1999-09-17 | 389 |
| K962910 | SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY | GZJ | 1996-09-05 | 62 |
| K962332 | TENS/FES/NMES ELECTRODES | GZJ | 1996-07-31 | 44 |
| K961141 | EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220 | GXY | 1996-05-10 | 50 |
| K925466 | CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON | GYB | 1993-08-26 | 301 |
| K871222 | TANTONE MULTI-DAY #633 TENS ELECTRODE | GXY | 1987-05-29 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Uni-Patch, 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 Uni-Patch, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Uni-Patch, Inc.” (first 1987, latest 1999), across 3 product codes 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 Uni-Patch, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Uni-Patch, Inc. is 62 days.
Which FDA product codes appear under Uni-Patch, Inc.?
The most frequent FDA product codes under this applicant name are GXY (Electrode, Cutaneous, 3); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 2); GYB (Media, Electroconductive, 1).
Next steps
- See all 6 Uni-Patch, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GXY, Uni-Patch, 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, 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.