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510(k) K920644

F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND by Fairform Mfg., Co., Ltd. — Product Code JEQ

K920644 is an FDA 510(k) premarket notification submitted by Fairform Mfg., Co., Ltd. for the device "F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND". The FDA issued a decision of Substantially Equivalent on May 29, 1992. The device falls under product code JEQ (Toothbrush, Powered), a Class I device regulated under 21 CFR 872.6865. Fairform Mfg., Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1992
Date Received
February 12, 1992
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 Fairform Mfg., Co., Ltd.

  • K931637 — A013 FEMI-FORM FACIAL MASSAGER (March 28, 1994)
  • K931640 — AO11 BODY MASSAGER (March 28, 1994)
  • K931638 — FO96 HANDY MASSAGER (March 28, 1994)
  • K931636 — FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER (March 28, 1994)
  • K931639 — F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR (March 28, 1994)
  • K914703 — F383 RECHARGEABLE MINI MASSAGER (December 9, 1991)
  • K914706 — FO51/F151 GOLF MASSAGER (December 9, 1991)
  • K914705 — FO41 BODY MASSAGER (December 9, 1991)
  • K914704 — FO69 FANCY MASSAGER (December 9, 1991)
  • K914707 — F055 B.O. FANTASTIC RELAXER (December 9, 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