EMG Technology Co., Ltd.
Taichung City, TW
EMG TECHNOLOGY CO., LTD. appears in FDA device records in Taichung City, TW. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for EMG Technology Co., Ltd. between 2003 and 2011. The busiest year on record is 2003, with 3. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 3 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 3 |
| 2008 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K112421 | EMG SUCTION UNIT | JCX | Substantially Equivalent | |
| K072634 | EMG TRITON -COMP,MODEL NCA01-XXX SERIES | BTI | Substantially Equivalent | |
| K063448 | EMG AC/DC SUCTION UNIT | JCX | Substantially Equivalent | |
| K062888 | MIDDLE WHEEL DRIVE POWER CHAIR, CWD01 | ITI | Substantially Equivalent | |
| K052438 | EMG HANDLE NEBULIZER NB02 SERIES | CAF | Substantially Equivalent | |
| K043520 | EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | |
| K043238 | COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES | CAF | Substantially Equivalent | |
| K042349 | EMG MODEL SUA01 SUCTION UNIT | JCX | Substantially Equivalent | |
| K033206 | EPW FOLDABLE POWER WHEELCHAIR, EPW-03 | ITI | Substantially Equivalent | |
| K033204 | ESG 4-WHEEL SCOOTER, ESG-03 | INI | Substantially Equivalent | |
| K023148 | EPW POWERED WHEELCHAIR, GP-201 | ITI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003803075 | 3003803075 | EMG TECHNOLOGY CO., LTD. | 5F,4F.,No.3,Jingke 5th Rd., Nantun Dist.,, Taichung City 40852 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2642-2014 | Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric. | suction canister lids may have occluded ports. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
