Skip to content

Dynatron Soundhead DSH02

by Dynatronics Corp.

Dynatron Soundhead DSH02 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 10660584000345), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K031329

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10660584000345 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK031329 Date22 Oct 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K031329 decided 22 Oct 2003 Active
  • FDA GUDID UDI-DI 10660584000345 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K031329
  2. Listed FDA GUDID 10660584000345

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dynatron Soundhead
Generic name
Physical therapy ultrasound system applicator, hand-held
Model / reference
DSH02
Primary DI / UDI-DI
10660584000345
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
Not in Commercial Distribution
Size
Area/Surface Area — 2 Square centimeter

Related devices

Cleared under the same submission (K031329)

and 8 more cleared under K031329

Similar devices

Other devices filed under FDA product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat).

Other devices from Dynatronics Corp.

See all devices from Dynatronics Corp. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)