Name: Predicase
Price: 199 USD

K-number	K040512
Device name	LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401
Applicant	Well-Life Healthcare, Inc.
Product code	GZJ
Device class	Class II
Decision date	May 27, 2004
Decision	Substantially Equivalent
Regulation	882.5890

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 →

LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401

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