Rich-Mar Corp.: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Rich-Mar Corp.” (first 1976, latest 2004), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 68 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 | 17 | 17 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 9 | 9 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 5 | 5 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 3 | 3 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 | 2 |
| LIH | Interferential Current Therapy | 2 | 2 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
| INQ | Table, Powered | 1 | 1 |
| ITH | Equipment, Traction, Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
- Physical Medicine (37)
- Neurology (5)
- Radiology (1)
Most recent Rich-Mar Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040679 | RICH-MAR AUTOPRISM INFRARED LAMP | ILY | 2004-05-07 | 53 |
| K031018 | AUTOGEL PAD | MUI | 2003-12-08 | 252 |
| K032941 | AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE | IPF | 2003-10-22 | 30 |
| K021483 | RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND | IMI | 2002-09-13 | 128 |
| K013771 | MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE | IPF | 2002-01-18 | 66 |
| K013770 | MODIFICATION TO: WINNER ST-2 STIMULATOR | IPF | 2002-01-18 | 66 |
| K012848 | WINNER CM4 COMBINATION UNIT | GZJ | 2001-10-25 | 63 |
| K000808 | RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE | IPF | 2000-08-25 | 165 |
| K982544 | RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES | IMI | 1998-11-19 | 121 |
| K952089 | RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE | LIH | 1995-08-11 | 100 |
33 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Rich-Mar Corp..
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.
- Rich Mountain Medical Products, Inc. (7 510(k)s)
- Rich-Larky Company, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rich-Mar Corp.?
FDA lists 43 510(k) clearances under the applicant name “Rich-Mar Corp.” (first 1976, latest 2004), across 11 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 Rich-Mar Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rich-Mar Corp. is 68 days.
Which FDA product codes appear under Rich-Mar Corp.?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 17); IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, 9); IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat, 5).
Next steps
- See all 43 Rich-Mar Corp. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Rich-Mar Corp.'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.