Therapeutic Technologies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Therapeutic Technologies, Inc.” (first 1984, latest 2010), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| HCC | Device, Biofeedback | 1 | 1 |
| NBL | Light-Induced Fluorescence Caries Detector | 1 | 1 |
Review panels
- Physical Medicine (3)
- Dental (1)
- Neurology (1)
Most recent Therapeutic Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093705 | FUORECAM | NBL | 2010-04-23 | 143 |
| K900029 | SPECTRASTIM 2000 MUSCLE STIMULATOR | IPF | 1990-04-02 | 89 |
| K893964 | SPECTRASTIM TM 1000 | IPF | 1989-10-06 | 126 |
| K854277 | NEUROPATH 4000 | HCC | 1986-01-21 | 90 |
| K841112 | TTI REHABILATATION GYM SYS | IPF | 1984-04-04 | 20 |
Recalls
openFDA lists no recalls under a recalling firm named Therapeutic Technologies, 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.
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.
- Therapeutic Equipment Corp. (4 510(k)s)
- Therapeutic Recreation Systems, Inc. (2 510(k)s)
- Therapeutic Clinical Technologies, Inc. (1 510(k)s)
- Therapeutic Innovations, Inc. (1 510(k)s)
- Therapeutic Monitoring Systems (Tms), Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Therapeutic Technologies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Therapeutic Technologies, Inc.” (first 1984, latest 2010), across 3 product codes in 3 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 Therapeutic Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Therapeutic Technologies, Inc. is 90 days.
Which FDA product codes appear under Therapeutic Technologies, Inc.?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 3); HCC (Device, Biofeedback, 1); NBL (Light-Induced Fluorescence Caries Detector, 1).
Next steps
- See all 5 Therapeutic Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Therapeutic Technologies, 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.