Th Charters, Inc.: FDA clearances and approvals
Th Charters, Inc. has 8 FDA 510(k) clearances (first 1980, latest 1987), across 3 product codes in 2 review panels. Median 510(k) review time: 54 days.
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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 4 | 4 |
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| ISD | Exerciser, Measuring | 2 | 2 |
Review panels
- Neurology (4)
- Physical Medicine (4)
Most recent Th Charters, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873357 | ELECTROBLOC TRANS. ELECTRICAL NERVE BLOCK GENERA. | GZJ | 1987-10-26 | 67 |
| K861501 | EXER-STIM 2 | GZJ | 1986-05-08 | 15 |
| K851967 | TORQUE FEEDBACK METER | ISD | 1985-07-19 | 74 |
| K851946 | REMOTE SPEED CONTROL | ISD | 1985-07-19 | 77 |
| K834215 | MINI-1 TRANSCUTANEOUS ELEC-NERVE STIM | GZJ | 1984-01-03 | 29 |
| K831850 | NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE | GZJ | 1983-07-19 | 40 |
| K822056 | EXER-STIM CONTROLLER | IPF | 1982-10-06 | 85 |
| K800486 | STIM-EX 201 | IPF | 1980-03-19 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Th Charters, 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.
Frequently asked questions
How many FDA 510(k) clearances does Th Charters, Inc. have?
Th Charters, Inc. has 8 FDA 510(k) clearances (first 1980, latest 1987), across 3 product codes in 2 review panels.
How long does FDA take to clear Th Charters, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Th Charters, Inc.'s cleared 510(k)s is 54 days.
What devices does Th Charters, Inc. make?
Its most frequent FDA product codes are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 4); IPF (Stimulator, Muscle, Powered, 2); ISD (Exerciser, Measuring, 2).
Has Th Charters, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Th Charters, Inc. Related entities may recall under other names.
Next steps
- See all 8 Th Charters, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Th Charters, 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.