MANGAR BOOSTER
Device Facts
| Record ID | K905414 |
|---|---|
| Device Name | MANGAR BOOSTER |
| Applicant | Northfleet Management Group, Inc. |
| Product Code | FNG · General Hospital |
| Decision Date | Mar 5, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5500 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An AC-powered lift is an electrically powered device either fixed or mobile, used to lift and transport patients in the horizontal or other required position from one place to another, as from a bed to a bath. The device includes straps and slings to support the patient.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
