Oriental Medical Supplies, Inc.: FDA clearances and approvals
Oriental Medical Supplies, Inc. has 6 FDA 510(k) clearances (first 1985, latest 1989), across 3 product codes in 3 review panels. Median 510(k) review time: 96 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 | 3 | 3 |
| IMD | Pack, Hot Or Cold, Disposable | 2 | 2 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
- Neurology (3)
- Physical Medicine (2)
- General Hospital (1)
Most recent Oriental Medical Supplies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K893372 | LATEX EXAMINATION GLOVES | LYY | 1989-08-21 | 116 |
| K871666 | MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATOR | GZJ | 1987-06-25 | 58 |
| K853442 | MODEL 804 (TENS) | GZJ | 1985-12-09 | 115 |
| K853416 | MES-TENS(TENS) | GZJ | 1985-11-07 | 85 |
| K852610 | HOT PACK | IMD | 1985-08-12 | 54 |
| K850566 | MARUKYR-BAN / HOT OR HEAT PACK | IMD | 1985-05-29 | 106 |
Recalls
openFDA lists no recalls under a recalling firm named Oriental 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 Oriental Medical Supplies, Inc. have?
Oriental Medical Supplies, Inc. has 6 FDA 510(k) clearances (first 1985, latest 1989), across 3 product codes in 3 review panels.
How long does FDA take to clear Oriental Medical Supplies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Oriental Medical Supplies, Inc.'s cleared 510(k)s is 96 days.
What devices does Oriental Medical Supplies, Inc. make?
Its most frequent FDA product codes are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 3); IMD (Pack, Hot Or Cold, Disposable, 2); LYY (Latex Patient Examination Glove, 1).
Has Oriental Medical Supplies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Oriental Medical Supplies, Inc. Related entities may recall under other names.
Next steps
- See all 6 Oriental Medical Supplies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Oriental 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.