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Echo Ultrasound Device (USA)

THERMOTEK, INC. · Model 0V52XX1002JK01 · UDI-DI 00850033615340

IMIPFW Prescription
1
510(k) clearances
60
Adverse events
3
Recalls
24
Facilities

Description

Echo Ultrasound Device (USA), Single

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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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.