PNEUMATHERM
Device Facts
| Record ID | K922089 |
|---|---|
| Device Name | PNEUMATHERM |
| Applicant | National Pain Institute |
| Product Code | IRT · Physical Medicine |
| Decision Date | Feb 23, 1993 |
| 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.
