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510(k) K931636

FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER by Fairform Mfg., Co., Ltd. — Product Code ISA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1994
Date Received
March 31, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Therapeutic, Electric
Device Class
Class I
Regulation Number
890.5660
Review Panel
PM
Submission Type

Other clearances by Fairform Mfg., Co., Ltd.

  • K931640 — AO11 BODY MASSAGER (March 28, 1994)
  • K931639 — F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR (March 28, 1994)
  • K931637 — A013 FEMI-FORM FACIAL MASSAGER (March 28, 1994)
  • K931638 — FO96 HANDY MASSAGER (March 28, 1994)
  • K920644 — F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND (May 29, 1992)
  • K914705 — FO41 BODY MASSAGER (December 9, 1991)
  • K914829 — FO92 SEATING MASSAGER (December 9, 1991)
  • K914703 — F383 RECHARGEABLE MINI MASSAGER (December 9, 1991)
  • K914707 — F055 B.O. FANTASTIC RELAXER (December 9, 1991)
  • K914830 — A101 LITESSAGER (December 9, 1991)

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