Oms Medical Supplies, Inc.: FDA clearances and approvals
Oms Medical Supplies, Inc. has 6 FDA 510(k) clearances (first 1988, latest 1996), across 3 product codes in 3 review panels. Median 510(k) review time: 180 days.
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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 4 | 4 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| MQX | Needle, Acupuncture, Single Use | 1 | 1 |
Review panels
- Neurology (4)
- General Hospital (1)
- Physical Medicine (1)
Most recent Oms Medical Supplies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963194 | ITO ACUPUNCTURE NEEDLES | MQX | 1996-08-23 | 8 |
| K920266 | TENS MODEL 240Z | GZJ | 1992-12-03 | 317 |
| K904388 | POINTER F-3 TENS | GZJ | 1991-06-04 | 252 |
| K904332 | MSTIM-2000 EMS | IPF | 1991-05-01 | 222 |
| K894964 | K-2 TENS OR MED TENS | GZJ | 1990-01-04 | 139 |
| K884210 | TX-7 (TENS) (IC-1107) | GZJ | 1988-12-12 | 67 |
Recalls
openFDA lists no recalls under a recalling firm named Oms Medical Supplies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Oms Medical Supplies, Inc. have?
Oms Medical Supplies, Inc. has 6 FDA 510(k) clearances (first 1988, latest 1996), across 3 product codes in 3 review panels.
How long does FDA take to clear Oms Medical Supplies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Oms Medical Supplies, Inc.'s cleared 510(k)s is 180 days.
What devices does Oms Medical Supplies, Inc. make?
Its most frequent FDA product codes are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 4); IPF (Stimulator, Muscle, Powered, 1); MQX (Needle, Acupuncture, Single Use, 1).
Has Oms Medical Supplies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Oms Medical Supplies, Inc. Related entities may recall under other names.
Next steps
- See all 6 Oms Medical Supplies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Oms Medical Supplies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.