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510(k) K063448

EMG AC/DC SUCTION UNIT by Emg Technology Co., Ltd. — Product Code JCX

K063448 is an FDA 510(k) premarket notification submitted by Emg Technology Co., Ltd. for the device "EMG AC/DC SUCTION UNIT". The FDA issued a decision of Substantially Equivalent on November 30, 2006. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Emg Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2006
Date Received
November 15, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

Other clearances by Emg Technology Co., Ltd.

  • K112421 — EMG SUCTION UNIT (September 1, 2011)
  • K072634 — EMG TRITON -COMP,MODEL NCA01-XXX SERIES (November 19, 2008)
  • 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)

Other clearances for product code JCX

  • K250964 — Protable Phlegm Suction Unit (JMA D01) (May 11, 2026)
  • K243638 — MV Flow Aspiration Pump (MVFLOWPMP01) (June 13, 2025)
  • K251111 — Cary (May 7, 2025)
  • K243418 — Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing (December 2, 2024)
  • K233428 — Easycess Aspiration Pump (November 3, 2023)
  • K222552 — 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specime (December 9, 2022)
  • K182950 — Acare Suction Unit (August 23, 2019)
  • K190789 — IntelliCartTM System (April 24, 2019)
  • K190105 — ZOOM Aspiration Pump (February 21, 2019)
  • K180115 — TWBM Pump (July 24, 2018)

FDA data resources