Dynasound 801
by Dynawave, Corp. 510(k)
Active
510(k) K811159
Overview
The Dynasound 801 is an ultrasonic diathermy device for use in applying therapeutic deep heat, classified under product code IMI and regulation number 890.5300. It is a Class II medical device that received FDA 510(k) clearance (K811159) on May 27, 1981, as substantially equivalent to a predicate device.
The device is manufactured by Dynawave, Corp. and is intended for use in physical medicine settings. It is supplied as a reusable therapy system, with no indication of sterility, single-use designation, or MRI safety in the provided data. Storage and handling details are not specified in the device record.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811159 | Date27 May 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IMI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5300
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dynawave, Corp.
Questions
What is the Dynasound 801 used for?
The Dynasound 801 is an ultrasonic diathermy device intended for applying therapeutic deep heat in physical medicine settings, as indicated by its product code IMI and regulation number 890.5300.
Is the Dynasound 801 a single-use or reusable device?
The Dynasound 801 is supplied as a reusable therapy system, with no indication of single-use designation in the device data, meaning it is designed for repeated use after appropriate cleaning and maintenance.
When was the Dynasound 801 cleared by the FDA?
The Dynasound 801 received FDA 510(k) clearance on May 27, 1981, under submission K811159, as substantially equivalent to a predicate device.
Is the Dynasound 801 sterile when supplied?
The device data provides no indication of sterility for the Dynasound 801; it is not labeled or described as sterile, so users should follow standard cleaning protocols for reusable physical medicine equipment.
What regulatory classification does the Dynasound 801 have?
The Dynasound 801 is classified as a Class II medical device under FDA regulations, with product code IMI and regulation number 890.5300, based on its 510(k) clearance as substantially equivalent to a predicate.