Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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Over The Counter Thermal Treatment For Acne.
- Page Type
- Product Code
- Definition
- For the treatment of mild to moderate inflammatory acne.
- Physical State
- In addition to the device, there may be batteries, re-charger, USB cable
- Technical Method
- Deliver heat to acne to kill propionibacterium acne virus
- Target Area
- Acne/pimples
- Regulation Medical Specialty
- Physical Medicine
- Review Panel
- General and Plastic Surgery
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 890.5740
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 890.5740 Powered heating pad
§ 890.5740 Powered heating pad.
(a) 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.
(b) 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.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]