Home / 510(k) Clearances / K033206

510(k) K033206

EPW FOLDABLE POWER WHEELCHAIR, EPW-03 by Emg Technology Co., Ltd. — Product Code ITI

K033206 is an FDA 510(k) premarket notification submitted by Emg Technology Co., Ltd. for the device "EPW FOLDABLE POWER WHEELCHAIR, EPW-03". The FDA issued a decision of Substantially Equivalent on December 18, 2003. The device falls under product code ITI (Wheelchair, Powered), a Class II device regulated under 21 CFR 890.3860. Emg Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2003
Date Received
October 2, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Powered
Device Class
Class II
Regulation Number
890.3860
Review Panel
PM
Submission Type

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).

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)
  • 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)
  • K033204 — ESG 4-WHEEL SCOOTER, ESG-03 (November 12, 2003)
  • K023148 — EPW POWERED WHEELCHAIR, GP-201 (January 24, 2003)

Other clearances for product code ITI

  • K261149 — Electric Wheelchair (DY611A-2, DY612A-1) (July 10, 2026)
  • K261396 — Electric Wheelchair (July 8, 2026)
  • K261164 — Electric wheelchair (XW-LY007 ) (July 7, 2026)
  • K260937 — Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) (June 24, 2026)
  • K253812 — Power Wheelchair (W5915B, W5915C, W5915D) (June 18, 2026)
  • K260335 — Electric Wheelchair (S500-6) (June 15, 2026)
  • K261175 — WHILL (WHILL Model C2) (June 12, 2026)
  • K260056 — Power Wheelchair (N5515A, N5516, N5517A, N5519) (June 5, 2026)
  • K260373 — Electric Wheelchair (DF506) (June 3, 2026)
  • K253241 — Electric Wheelchair (Y207BL) (May 13, 2026)

FDA data resources