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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) clearances
11
PMA records
0
Recall records
1
Registered establishments
1

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
510(k) clearance decisions for EMG Technology Co., Ltd., by decision year
YearClearances
20033
20041
20052
20063
20081
20111
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K112421EMG SUCTION UNITJCXSubstantially Equivalent
K072634EMG TRITON -COMP,MODEL NCA01-XXX SERIESBTISubstantially Equivalent
K063448EMG AC/DC SUCTION UNITJCXSubstantially Equivalent
K062888MIDDLE WHEEL DRIVE POWER CHAIR, CWD01ITISubstantially Equivalent
K052438EMG HANDLE NEBULIZER NB02 SERIESCAFSubstantially Equivalent
K043520EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATORCAWSubstantially Equivalent
K043238COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIESCAFSubstantially Equivalent
K042349EMG MODEL SUA01 SUCTION UNITJCXSubstantially Equivalent
K033206EPW FOLDABLE POWER WHEELCHAIR, EPW-03ITISubstantially Equivalent
K033204ESG 4-WHEEL SCOOTER, ESG-03INISubstantially Equivalent
K023148EPW POWERED WHEELCHAIR, GP-201ITISubstantially Equivalent

Registered establishments

FDA registered establishments for EMG Technology Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30038030753003803075EMG TECHNOLOGY CO., LTD.5F,4F.,No.3,Jingke 5th Rd., Nantun Dist.,, Taichung City 40852 TW2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2642-2014Vac-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 IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain