General Theraphysical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “General Theraphysical, Inc.” (first 1978, latest 1978), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 64 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 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 2 | 2 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
Review panels
- Physical Medicine (6)
- Neurology (1)
Most recent General Theraphysical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K781319 | THERAPY APPAR. 422 INTERFERENTIAL | IPF | 1978-10-03 | 64 |
| K781318 | DYNATRON 406 ELECTROTHERAPY APPARATUS | IPF | 1978-10-03 | 64 |
| K781317 | ULTRASONIC THERAPY APPARATUS, 407 | IMI | 1978-10-03 | 64 |
| K781315 | MUSCLE STIMULATION APPARATUS | IPF | 1978-10-03 | 64 |
| K781314 | THERAPY UNIT & ELECTRODIAG. | GXY | 1978-10-03 | 64 |
| K781320 | SHORTWAVE THERAPY APPAR. CURAMED 401 | IMJ | 1978-09-27 | 58 |
| K781316 | PULSED AND CONTINUOUS SHORTWAVE APPAR. | IMJ | 1978-09-27 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named General Theraphysical, 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.
- General Electric Co. (254 510(k)s)
- General Diagnostics (39 510(k)s)
- General Electric Medical Systems Information Techn (33 510(k)s)
- General Biometrics, Inc. (23 510(k)s)
- General Medical Co. (15 510(k)s)
- General Surgical Innovations (14 510(k)s)
- General X-Ray, Inc. (14 510(k)s)
- General Devices (13 510(k)s)
- General Physiotherapy, Inc. (9 510(k)s)
- General Medical Merate S.P.A (7 510(k)s)
- General Atomics (6 510(k)s)
- General Electric Medical Systems (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under General Theraphysical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “General Theraphysical, Inc.” (first 1978, latest 1978), across 4 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 General Theraphysical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name General Theraphysical, Inc. is 64 days.
Which FDA product codes appear under General Theraphysical, Inc.?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 3); IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat, 2); GXY (Electrode, Cutaneous, 1).
Next steps
- See all 7 General Theraphysical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IPF, General Theraphysical, 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.