Physio Technology, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Physio Technology, Inc.” (first 1984, latest 1988), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 69 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 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 2 | 2 |
| HCC | Device, Biofeedback | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| ISA | Massager, Therapeutic, Electric | 1 | 1 |
| LIH | Interferential Current Therapy | 1 | 1 |
Review panels
- Physical Medicine (8)
- Neurology (2)
Most recent Physio Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883893 | OMNISOUND(TM) 3000 | IMG | 1988-11-01 | 48 |
| K874076 | MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR | IPF | 1988-01-04 | 90 |
| K861039 | OMNIVAC (VACUUM ELECTRODE SYSTEM) | LIH | 1986-09-26 | 192 |
| K850850 | AUTOMOVE/OMNISTIM IV-ELECTRICAL MUSCLE STIMULATOR | IPF | 1985-07-01 | 122 |
| K850851 | G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S | ISA | 1985-06-25 | 116 |
| K850849 | MYOMETER EMG BIOFEEDBACK DEVICE | HCC | 1985-05-31 | 91 |
| K843372 | OMNISOUND THERAPY UNIT | IMI | 1984-09-18 | 21 |
| K843351 | OMNISTIM II COMBIN. THERAPY SYS | IMG | 1984-09-18 | 22 |
| K841874 | MEGA PULSE THERAPY UNIT | IMJ | 1984-05-31 | 24 |
| K841278 | OMNISTIM III INTERFERENTIAL THERAPY | IPF | 1984-04-24 | 27 |
Recalls
FDA recall records list no recalls under a recalling firm named Physio 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.
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.
- Physio-Control Corp. (94 510(k)s)
- Physio Systems, Inc. (3 510(k)s)
- Physio, Inc. (1 510(k)s)
- Physio Designs, Inc. (1 510(k)s)
- Physio-Dyne (1 510(k)s)
- Physio-Dyne Industrument Corp. (1 510(k)s)
- Physio-Dyne Instrument Corp. (1 510(k)s)
- Physio Tronics Corp. (1 510(k)s)
- Physio Ventures, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Physio Technology, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Physio Technology, Inc.” (first 1984, latest 1988), across 7 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 Physio Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Physio Technology, Inc. is 69 days.
Which FDA product codes appear under Physio Technology, Inc.?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 3); IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat, 2); HCC (Device, Biofeedback, 1).
Next steps
- See all 10 Physio Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Physio Technology, Inc.'s most frequent
Compiled by Caduvo from public U.S. government records. Counts cover filings under the applicant name shown on this page only. Review days run from FDA receipt to decision. Not reviewed or endorsed by FDA or any other agency, or by the companies named. Not regulatory advice. Report an error in this data. Data and corrections policy.