RegWardenFDA facility compliance records
Facility

PERMOBIL (KUNSHAN) CO., LTD

5 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2017: 1 recalls; 2018: 1 recalls; 2023: 1 recalls; 2024: 1 recalls; 2025: 1 recalls120171201820192020202120221202312024120252026
  • Recalls (5)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2025-06-19
    This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may create an unstable condition in certain circumstances.
  • Class IIOngoing2024-02-29
    This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall from the wheelchair or the wheelchair to tip over,
  • Class IIOngoing2023-05-10
    When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on the power assist device continues to run and the user may not be able to stop the device using tap gestures.
  • Class IITerminated2018-08-15
    This correction decision has been made because of a potential failure of one or both backrest bars providing back support. If one or both back support telescoping bars fail the user could fall back leading to a potential injury.
  • Class IITerminated2017-09-01
    There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “PERMOBIL (KUNSHAN) CO., LTD (FEI 3009303347) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009303347-permobil-kunshan-co-ltd/

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