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Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

FDA product code IMI · Class 2 · Physical Medicine

161
Registered devices
60
Adverse events
3
Recalls
89
510(k) clearances

Devices with this code

Dynatron Soundhead — Dynatronics CorporationCHATTANOOGA — DJO, LLCWINNER EVO PACKAGE — COMPASS HEALTH BRANDS CORP.Echo CTN, DRESSINGS, USND, USA, QTY 4 BOXES — THERMOTEK, INC.CHATTANOOGA — DJO, LLCOpus Colibri 1mm Single-use Tip Set (X6) — ALMA LASERS LTD.Echo BOX, DRESSING & GEL POD PACK, USND, PRC — THERMOTEK, INC.50 Plus Soundhead — Dynatronics CorporationCHATTANOOGA — DJO, LLCCHATTANOOGA — DJO, LLCWINNER EVO PACKAGE — COMPASS HEALTH BRANDS CORP.Opus Colibri 0.7mm Single-use Tip (X1) — ALMA LASERS LTD.Echo POWER SUPPLY, CORD, SINGLE, USND — THERMOTEK, INC.Richmar — South Dakota Partners Inc.Therasound3 Standard 120V — COMPASS HEALTH BRANDS CORP.THERASOUND EVO PACKAGE — COMPASS HEALTH BRANDS CORP.Solaris Soundhead — Dynatronics Corporation50 Plus Soundhead — Dynatronics CorporationDynatron 25 Series 125B — Dynatronics CorporationAccent Prime System 120V For Inc. — ALMA LASERS LTD.Dynatron Solaris Plus 709 — Dynatronics CorporationWINNER EVO PACKAGE — COMPASS HEALTH BRANDS CORP.CHATTANOOGA — DJO, LLCDynatron Soundhead — Dynatronics Corporation

Recent recalls

DateFirmReason
2008-02-28Chattanooga Corp IncDevice may fail to administer therapy during use.
2008-02-28Chattanooga Corp IncDevice may fail to administer therapy during use.
2005-01-05Sybaritic, IncDevice is performing functions that are not cleared in the 510(k).

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.