Jace Tri-Stim Device

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K931781 ↗

FDA Product Code

IPF

Device Class

Class II

Regulation

21 CFR Part 890.5850

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Jace Model W550 Wrist Cpm Device

  Class I

  FDA 510(k) K920380 Active Cleared 11 Feb 1992

• Jace Model H440 Hand Cpm Device

  Class I

  FDA 510(k) K931016 Active Cleared 22 Jun 1994

• Jace Knee Extension System -- Modification

  Class I

  FDA 510(k) K922185 Active Cleared 11 Jun 1992

• Artromot-E, Elbow / Artromot-S, Shoulder Cmp Mod.

  Class I

  FDA 510(k) K933059 Active Cleared 22 Jun 1994

• Jace Model Pm-410 Hand Cpm Device

  Class I

  FDA 510(k) K921351 Active Cleared 4 May 1992

• What is the primary clinical application for the Jace Tri-Stim Device?

  The Jace Tri-Stim Device is specifically designed to deliver electrical stimulation for use in physical medicine applications.

• What is the regulatory status of this nerve stimulator?

  The Jace Tri-Stim Device is authorized under FDA 510(k) clearance, specifically identified by the k-number K931781. It underwent a traditional premarket notification process and was found to be substantially equivalent to existing devices.

• Who is the manufacturer of the Jace Tri-Stim Device?

  This device is manufactured by Jace Systems, Inc., located in Moorestown, New Jersey.