INY · Bed, Patient Rotation, Manual
Physical Medicine · 21 CFR 890.5180 · Class 1
Overview
| Product Code | INY |
|---|---|
| Device Name | Bed, Patient Rotation, Manual |
| Regulation | 21 CFR 890.5180 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A manual patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, or to aid circulation.
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 § 890.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K851875 | KINNET | Kinetic Concepts, Inc. | Aug 22, 1985 | SESE |
Top Applicants
- Kinetic Concepts, Inc. — 1 clearance
