Overload Warning Device

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K770405 ↗

FDA Product Code

IRN

Device Class

Class II

Regulation

21 CFR Part 890.5575

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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See all devices from Synthes (Usa) →

• What is the Overload Warning Device used for?

  The Overload Warning Device is designed to provide overload warnings in physical medicine applications, functioning as an external limb-powered warning device to alert users when excessive force or load is detected during use.

• How is the Overload Warning Device supplied and cleared for use?

  The device is supplied as a Class II medical device with special controls and was cleared via the FDA 510(k) pathway under submission K770405, determined to be substantially equivalent and granted clearance on March 10, 1977.

• What regulatory classification and pathway apply to the Overload Warning Device?

  The Overload Warning Device is classified as a Class II medical device under regulation number 890.5575, with product code IRN, and received clearance through the traditional FDA 510(k) process based on substantial equivalence.