Rs Medical: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Rs Medical” (first 1993, latest 2012), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 152 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 | 1 | 156 |
| 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 | 8 | 8 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| NYN | Stimulator, Electrical, Transcutaneous, For Arthritis | 1 | 1 |
Review panels
- Physical Medicine (8)
- Neurology (2)
Most recent Rs Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112348 | RS-4I MUSCLE STIMULATOR | IPF | 2012-01-19 | 156 |
| K090951 | RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG | GXY | 2009-06-05 | 63 |
| K062325 | RS-4I MUSCLE STIMULATOR FAMILY | NYN | 2007-04-13 | 247 |
| K032652 | RS-4I MUSCLE STIMULATOR FAMILY | IPF | 2003-09-12 | 15 |
| K021763 | RS2MI MUSCLE STIMULATOR FAMILY | IPF | 2002-06-13 | 15 |
| K000114 | RS-4M+MUSCLE STIMULATOR | IPF | 2000-08-10 | 209 |
| K990697 | RS-4V MUSCLE STIMULATOR | IPF | 1999-06-18 | 107 |
| K953136 | RS-4M | IPF | 1995-11-30 | 147 |
| K920389 | RS-2 NEUROMUSCULAR STIMULATOR | IPF | 1993-01-28 | 364 |
| K920388 | RS-1 NEUROMUSCULAR STIMULATOR | IPF | 1993-01-28 | 364 |
Recalls
openFDA lists no recalls under a recalling firm named Rs Medical.
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.
Device clinical trials
An industry sponsor named Rs Medical is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00701506: Patterned Electrical Neuromuscular Stimulation and Therapeutic Exercise for Osteoarthritis of the Knee: Pilot Study (Completed, started 2008-05)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rs Medical?
FDA lists 10 510(k) clearances under the applicant name “Rs Medical” (first 1993, latest 2012), across 3 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 Rs Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rs Medical is 152 days.
Which FDA product codes appear under Rs Medical?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 8); GXY (Electrode, Cutaneous, 1); NYN (Stimulator, Electrical, Transcutaneous, For Arthritis, 1).
Next steps
- See all 10 Rs Medical clearances with predicates and recalls
- Run predicate analysis for product code IPF, Rs Medical'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.