Intl. Medical Equipment Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Intl. Medical Equipment Corp.” (first 1981, latest 1983), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| ITI | Wheelchair, Powered | 3 | 3 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 | 1 |
| IQC | Wheelchair, Special Grade | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Intl. Medical Equipment Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832745 | OC3 FLYER | ITI | 1983-09-20 | 36 |
| K832325 | BASE ONLY, POWER WHEELCHAIR | ITI | 1983-08-12 | 28 |
| K832322 | BASE ONLY, TORONTO CHAIR | IQC | 1983-08-12 | 28 |
| K832321 | ACCES. HEAD CONTROL-POWERED CHEELCHAIR | — | 1983-08-12 | 28 |
| K813104 | POWER DRIVE WHEELCR | ITI | 1981-11-20 | 17 |
| K803307 | MATTRESS, AIR FLOATATION, ALTERN. PRESS. | FNM | 1981-01-13 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Intl. Medical Equipment 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.
- Intl. Diagnostic Technology (29 510(k)s)
- Intl. Immunoassay Laboratories, Inc. (27 510(k)s)
- Intl. Medical, Inc. (17 510(k)s)
- Intl. Remote Imaging Systems (14 510(k)s)
- Intl. Medical Devices , Ltd. (12 510(k)s)
- Intl. Playtex, Inc. (10 510(k)s)
- Intl. Business Machines (8 510(k)s)
- Intl. Bioclinical, Inc. (6 510(k)s)
- Intl. Diagnostic, Inc. (6 510(k)s)
- Intl. Medical Consultants (6 510(k)s)
- Intl. Ophthalmic Industries Corp. (6 510(k)s)
- Intl. Trade Management Co. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intl. Medical Equipment Corp.?
FDA lists 6 510(k) clearances under the applicant name “Intl. Medical Equipment Corp.” (first 1981, latest 1983), across 4 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 Intl. Medical Equipment Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intl. Medical Equipment Corp. is 28 days.
Which FDA product codes appear under Intl. Medical Equipment Corp.?
The most frequent FDA product codes under this applicant name are ITI (Wheelchair, Powered, 3); FNM (Mattress, Air Flotation, Alternating Pressure, 1); IQC (Wheelchair, Special Grade, 1).
Next steps
- See all 6 Intl. Medical Equipment Corp. clearances with predicates and recalls
- Run predicate analysis for product code ITI, Intl. Medical Equipment 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, 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.