K-number	K252831
Device name	Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
Applicant	Dolanvy (Suzhou) Medical Technology Co., Ltd.
Product code	KPI
Device class	Class II
Decision date	Apr 28, 2026
Decision	Substantially Equivalent
Regulation	876.5320

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Pelvic Floor Treatment Device (models DLR-8920 through DLR-8927) is a non-invasive electromagnetic stimulation device designed to rehabilitate weak pelvic floor muscles and restore neuromuscular control for treating urinary incontinence in women. It is intended for prescription use.

Technological characteristics

Not stated in this summary.

Test standards cited

The device is subject to the Quality Management System Regulation (QMSR) including ISO 13485 clauses for design controls, nonconforming product handling, corrective action, and preventative action. However, specific test methods or consensus standards used for this device are not detailed in this clearance summary.

Substantial equivalence argument

The device was determined to be substantially equivalent to legally marketed predicate devices that predate May 28, 1976, or to reclassified devices not requiring premarket approval. The specific predicate device(s) and comparative testing data are not detailed in this summary document.

Extracted by AI from the official FDA summary PDF →

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 →

Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)

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