NHH · Device, Discharge, Electrostatic (For Pain Relief)
Physical Medicine · 21 CFR 890.5500 · Class 2
Overview
| Product Code | NHH |
|---|---|
| Device Name | Device, Discharge, Electrostatic (For Pain Relief) |
| Regulation | 21 CFR 890.5500 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.
Classification Rationale
Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K042686 | ENERGEX | Energex Systems, Inc. | Jun 16, 2005 | SESE |
| K013094 | ORTHOSONIX ENERGEX | Orthosonix, Inc. | Dec 14, 2001 | SESE |
Top Applicants
- Energex Systems, Inc. — 1 clearance
- Orthosonix, Inc. — 1 clearance
