EMG Technology Co., Ltd.
FDA Regulatory Profile
EMG Technology Co., Ltd. appears in FDA public data with 1 recall, 11 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2642-2014, Class II) was initiated on August 3, 2014. Its most recent 510(k) clearance was granted on September 1, 2011.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 11
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2642-2014 | Class II | Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is in | August 3, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K112421 | EMG SUCTION UNIT | September 1, 2011 |
| K072634 | EMG TRITON -COMP,MODEL NCA01-XXX SERIES | November 19, 2008 |
| K063448 | EMG AC/DC SUCTION UNIT | November 30, 2006 |
| K062888 | MIDDLE WHEEL DRIVE POWER CHAIR, CWD01 | October 24, 2006 |
| K052438 | EMG HANDLE NEBULIZER NB02 SERIES | January 31, 2006 |
| K043520 | EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR | October 21, 2005 |
| K043238 | COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES | July 6, 2005 |
| K042349 | EMG MODEL SUA01 SUCTION UNIT | December 16, 2004 |
| K033206 | EPW FOLDABLE POWER WHEELCHAIR, EPW-03 | December 18, 2003 |
| K033204 | ESG 4-WHEEL SCOOTER, ESG-03 | November 12, 2003 |
| K023148 | EPW POWERED WHEELCHAIR, GP-201 | January 24, 2003 |