Emg Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Emg Technology Co., Ltd.” (first 2003, latest 2011), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 108 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 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 3 | 3 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
| INI | Vehicle, Motorized 3-Wheeled | 1 | 1 |
Review panels
Most recent Emg Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112421 | EMG SUCTION UNIT | JCX | 2011-09-01 | 9 |
| K072634 | EMG TRITON -COMP,MODEL NCA01-XXX SERIES | BTI | 2008-11-19 | 428 |
| K063448 | EMG AC/DC SUCTION UNIT | JCX | 2006-11-30 | 15 |
| K062888 | MIDDLE WHEEL DRIVE POWER CHAIR, CWD01 | ITI | 2006-10-24 | 28 |
| K052438 | EMG HANDLE NEBULIZER NB02 SERIES | CAF | 2006-01-31 | 147 |
| K043520 | EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR | CAW | 2005-10-21 | 305 |
| K043238 | COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES | CAF | 2005-07-06 | 226 |
| K042349 | EMG MODEL SUA01 SUCTION UNIT | JCX | 2004-12-16 | 108 |
| K033206 | EPW FOLDABLE POWER WHEELCHAIR, EPW-03 | ITI | 2003-12-18 | 77 |
| K033204 | ESG 4-WHEEL SCOOTER, ESG-03 | INI | 2003-11-12 | 41 |
1 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-08-03.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Emg Technology Co., Ltd. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Emg Technology Co., Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Emg Technology Co., Ltd.” (first 2003, latest 2011), across 6 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 Emg Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Emg Technology Co., Ltd. is 108 days.
Which FDA product codes appear under Emg Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are ITI (Wheelchair, Powered, 3); JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered, 3); CAF (Nebulizer (Direct Patient Interface), 2).
Next steps
- See all 11 Emg Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ITI, Emg Technology Co., Ltd.'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.