Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
The Nonthermal Shortwave Therapy Device is an over-the-counter device that uses nonthermal pulsed electromagnetic energy for the treatment of pain in the Physical Medicine specialty. It is classified as FDA Class 2 under 21 CFR 890.5290, requiring 510(k) premarket notification, and is available for consumer use without a prescription. The device delivers electromagnetic fields to targeted tissue areas to provide pain relief. Product code PQY; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PQY
- Device Class
- FDA class 2
- Regulation Number
- 890.5290
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
Definition
Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.