Intermittent pressure measurement system.

(a) Identification. An intermittent pressure measurement system is an evaluative device intended for medical purposes, such as to measure the actual pressure between the body surface and the supporting media. (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]