Title 21

SECTION 890.1575

890.1575 Force-measuring platform.

§ 890.1575 Force-measuring platform.

(a) Identification. A force-measuring platform is a device intended for medical purposes that converts pressure applied upon a planar surface into analog mechanical or electrical signals. This device is used to determine ground reaction force, centers of percussion, centers of torque, and their variations in both magnitude and direction with time.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, 2001]