KNM · Device, Pressure Applying
Physical Medicine · 21 CFR 890.5765 · Class 1
Overview
| Product Code | KNM |
|---|---|
| Device Name | Device, Pressure Applying |
| Regulation | 21 CFR 890.5765 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
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.
Classification Rationale
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K811956 | AUTONORM & NERV-A-NORM | Autonomic Equipment Supply Co, | Jul 31, 1981 | SESE |
| K780312 | AUTONOM | Autonomic Equipment Supply Co, | Apr 5, 1978 | SESE |
Top Applicants
- Autonomic Equipment Supply Co, — 2 clearances
