21 CFR § 890.5765 Physical Medicine Devices

§ 890.5765 Pressure-applying device.

Current through Sep 8, 2026 · Read all of Part 890

(a) Identification. A pressure-applying device is a device intended for medical purposes to apply continuous pressure to the paravertebral tissues for muscular relaxation and neuro-inhibition. It consists of a table with an adjustable overhead weight that, in place of the therapist's hands, presses on the back of a prone patient.

(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 59 FR 63015, Dec. 7, 1994; 66 FR 38818, July 25, 2001]

← § 890.5760 Nonpowered lower extremity pressure wrap.§ 890.5800 Virtual reality behavioral therapy device for pain relief. →