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IMI

Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Product code
IMI
Device name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device class
Class 2
21 CFR
21 CFR 890.5300
Medical specialty
Physical Medicine
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
89 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-06-04.

NumberDecision dateApplicantDevice nameSummary
K2407882025-06-04Jkh Health Co., Ltd.Ultrasound StimulatorPDF
K2304722023-10-24Enraf-Nonius, B.V.Sonopuls 190PDF

2 summaries are archived here for direct download.

Official FDA classification page: IMI
Classification and pathway per current FDA publications. Data from openFDA (CC0).