BYN · Chair, Posture, For Cardiac And Pulmonary Treatment
Anesthesiology · 21 CFR 868.5365 · Class 1
Overview
| Product Code | BYN |
|---|---|
| Device Name | Chair, Posture, For Cardiac And Pulmonary Treatment |
| Regulation | 21 CFR 868.5365 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A posture chair for cardiac or pulmonary treatment is a device intended to assist in the rehabilitation and mobilization of patients with chronic heart or lung disease.
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 § 868.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K873039 | MODEL 820 TOP=TRAK | Sierra Laboratories, Inc. | Feb 11, 1988 | SESE |
Top Applicants
- Sierra Laboratories, Inc. — 1 clearance
