AKROTECH 4000
Device Facts
| Record ID | K923977 |
|---|---|
| Device Name | AKROTECH 4000 |
| Applicant | Lumex, Inc. |
| Product Code | IOQ · Physical Medicine |
| Decision Date | Feb 12, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5170 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.
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 § 890.9.
