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510(k) K896245

PLAK TRAC POWERED TOOTHBRUSH by Windmere Corp. — Product Code JEQ

K896245 is an FDA 510(k) premarket notification submitted by Windmere Corp. for the device "PLAK TRAC POWERED TOOTHBRUSH". The FDA issued a decision of Substantially Equivalent on March 28, 1990. The device falls under product code JEQ (Toothbrush, Powered), a Class I device regulated under 21 CFR 872.6865. Windmere Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1990
Date Received
October 30, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Toothbrush, Powered
Device Class
Class I
Regulation Number
872.6865
Review Panel
DE
Submission Type

Other clearances by Windmere Corp.

  • K980769 — WINDMERE MODEL DS-2 FOOT BATH (March 27, 1998)
  • K932904 — WINDMERE WAND MASSAGER (February 17, 1994)
  • K933974 — WINDMERE MASSAGE MATE (February 2, 1994)
  • K924237 — WINDMERE PRELUDE III (October 18, 1993)
  • K931086 — WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER (September 30, 1993)
  • K912659 — SOUND RELIEF (September 6, 1991)

Other clearances for product code JEQ

  • K200881 — Oral-B iO Test Drive Power Brush Trial Program Kit (August 27, 2020)
  • K141018 — ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBR (September 15, 2014)
  • K061351 — ORAL-B SONIC COMPLETE (June 5, 2006)
  • K061199 — ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES (May 31, 2006)
  • K040416 — SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 (July 2, 2004)
  • K022900 — BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES (November 14, 2002)
  • K012914 — SONICWAVE SONIC PLAQUE REMOVER (October 1, 2001)
  • K970381 — POWERED TOOTHBRUSH (April 18, 1997)
  • K943942 — TRAV-LER KIT (March 8, 1995)
  • K945248 — HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH (January 26, 1995)

FDA data resources