PES HOT/COLD COMPRESS
Device Facts
| Record ID | K962038 |
|---|---|
| Device Name | PES HOT/COLD COMPRESS |
| Applicant | Princeton Electronic Systems, Inc. |
| Product Code | IRT · Physical Medicine |
| Decision Date | Nov 13, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5740 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.
