← Back to catalogue

Trx Power Tilt And Recline System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K970521

by Motion Concepts

Identifiers

510(k) Number
K970521 FDA 510(k)
FDA Product Code
ITI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.3860 FDA 510(k)
Regulation Number
890.3860 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Trx Power Tilt And Recline System by Motion Concepts — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Motion Concepts

Sources (1)

  • FDA 510(k) K970521 24 fields · synced Jun 18, 2026