MARK VII THERMOREGULATION ASSIST SYSTEM
Device Facts
| Record ID | K900355 |
|---|---|
| Device Name | MARK VII THERMOREGULATION ASSIST SYSTEM |
| Applicant | Life Enhancement Technologies, LLC |
| Product Code | ILO · Physical Medicine |
| Decision Date | Feb 15, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5720 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.
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.
