POWERED TOOTHBRUSH— 510(k) K970381
Substantially EquivalentEmjoi Action USA, Ltd.
FDA 510(k) clearance K970381 for POWERED TOOTHBRUSH, Substantially Equivalent on 1997-04-18. Applicant: Emjoi Action USA, Ltd.. Device class: 1.
Clearance details
- Applicant
- Emjoi Action USA, Ltd.
- Product code
- Code JEQ
- Device class
- Class 1
- Regulation
- 21 CFR 872.6865
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westford, MA, US
Recent devices under product code JEQ
view all- K200881 — Oral-B iO Test Drive Power Brush Trial Program Kit
- K141018 — ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT
- K061351 — ORAL-B SONIC COMPLETE
- K061199 — ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
- K040416 — SONICARE ADVANCE TOOTHBRUSH, MODEL 4900
Adverse events under product code JEQ
product code JEQ- Injury
- 188
- Malfunction
- 2,818
- Total
- 3,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.