# K034017: Jeje Teether

- Pathway: 510(k) (Traditional)
- Applicant: Vibe 2000
- Decided: Oct 18, 2004 after 299 days
- Product code: MEF (Ring, Teething, Non-Fluid Filled)
- Device class: 1
- Regulation: 21 CFR 872.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Class I non-fluid filled teething rings: named in the summary without a submission number

## Indications for use
The JeJe Teether is intended for infants to play with and chew on, and to help soothe teething infants.

Source page: https://510kreport.com/device/K034017
Methodology: https://510kreport.com/methodology