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510(k) K232199

Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE) by Zhenjiang Assure Medical Equipment Co., Ltd. — Product Code IOR

K232199 is an FDA 510(k) premarket notification submitted by Zhenjiang Assure Medical Equipment Co., Ltd. for the device "Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE)". The FDA issued a decision of Substantially Equivalent on September 15, 2023. The device falls under product code IOR (Wheelchair, Mechanical), a Class I device regulated under 21 CFR 890.3850. Zhenjiang Assure Medical Equipment Co., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2023
Date Received
July 25, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Mechanical
Device Class
Class I
Regulation Number
890.3850
Review Panel
PM
Submission Type

A mechanical wheelchair is a manually 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/or require an assistive device for mobility.

Other clearances by Zhenjiang Assure Medical Equipment Co., Ltd.

  • K260319 — K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” wit (March 31, 2026)
  • K251159 — Power wheelchair (December 22, 2025)
  • K232230 — YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; (October 3, 2023)
  • K232198 — Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, (September 15, 2023)
  • K231320 — Zhenjiang Assure Mechanical Wheelchair,model:K1 (June 5, 2023)
  • K112816 — ZHENJIANG ASURE MECHANICAL WHEELCHAIR (April 18, 2012)

Other clearances for product code IOR

  • K261076 — Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) (June 22, 2026)
  • K261075 — Manual Wheelchair (MS01);Manual Wheelchair (MA01) (June 22, 2026)
  • K260849 — ICON 35; ICON 45; ICON 60; ICON 30FAF (June 11, 2026)
  • K260642 — Manual Wheelchair (LW01108) (June 2, 2026)
  • K260295 — Helio Kids; Apex P (May 28, 2026)
  • K254141 — Manual Wheelchair (DY01903(2)) (May 21, 2026)
  • K260121 — Manual Wheelchair (7101L, 7102LHD) (April 28, 2026)
  • K260319 — K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” wit (March 31, 2026)
  • K253632 — Manual Wheelchair (W50) (January 29, 2026)
  • K251886 — EmpowerRide NAVIGATOR (January 12, 2026)

FDA data resources