Name: Predicase
Price: 199 USD

K-number	K050410
Device name	HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)
Applicant	Hwang Sun Enterprise Co., Ltd.
Product code	IMI
Device class	Class II
Decision date	Jul 14, 2005
Decision	Substantially Equivalent
Regulation	890.5300

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)

Everything you need for a 510(k) submission. Nothing you don't.