QTV · Mattress And Bed Deck Cover (Medical Purposes)
General Hospital · 21 CFR 880.6190 · Class 1
Overview
| Product Code | QTV |
|---|---|
| Device Name | Mattress And Bed Deck Cover (Medical Purposes) |
| Regulation | 21 CFR 880.6190 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A mattress cover for medical purposes is a device intended for medical purposes that is used to protect a mattress. It may be electrically conductive or contain a germicide.
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 § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201876 | Soteria Bed Barrier | Trinity Guardion | Sep 1, 2022 | SESE |
Top Applicants
- Trinity Guardion — 1 clearance
