Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
Microwave Diathermy for Applying Therapeutic Deep Heat is a Physical Medicine device that uses microwave electromagnetic energy to generate deep tissue heating within muscles and joints, used to increase tissue temperature, reduce pain, decrease muscle spasm, and enhance tissue extensibility before therapeutic exercise. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IOA, regulated under 21 CFR 890.5275, within the Physical Medicine medical specialty. This device is eligible for third party review, meaning the 510(k) submission may be reviewed by an FDA-accredited third party organization.
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Basic Information
- Product Code
- IOA
- Device Class
- FDA class 2
- Regulation Number
- 890.5275
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K941567 | DIATHERMY DEVICE-MICROFOCUS | Apr 22, 1996 | Substantially Equivalent | Cheung Laboratories, Inc. |
| K895000 | NEMECTRON MICROWAVE | Jul 27, 1990 | Substantially Equivalent | Nemectron Medical, Inc. |
| K862029 | SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT | Jul 16, 1986 | Substantially Equivalent | Elmed, Inc. |
| K860082 | THERMOTRON 918 | Mar 27, 1986 | Substantially Equivalent | Medical Microwave Research Corp. |