Dynatron Soundhead ` WSH10
Dynatron Soundhead ` WSH10 is a Class II device made by Dynatronics Corp., cleared under FDA 510(k) K031329 on 22 Oct 2003 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10660584000291), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10660584000291 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031329 | Date22 Oct 2003 | StatusActive |
Official records
- AccessGUDID record 10660584000291
- FDA 510(k) database K031329
Across registries
- FDA 510(k) K031329 decided 22 Oct 2003 Active
- FDA GUDID UDI-DI 10660584000291 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K031329
- Listed FDA GUDID 10660584000291
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dynatron Soundhead `
- Generic name
- Physical therapy ultrasound system applicator, hand-held
- Model / reference
- WSH10
- Primary DI / UDI-DI
- 10660584000291
- 510(k) Number
- FDA product code
- IMI
- GMDN term
- Physical therapy ultrasound system applicator, hand-held
- Device class
- Class II
- Regulation number
- 890.5300
- GUDID distribution status
- In Commercial Distribution
- Size
- Area/Surface Area — 10.0 Square centimeter
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