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510(k) K914707

F055 B.O. FANTASTIC RELAXER by Fairform Mfg., Co., Ltd. — Product Code IRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1991
Date Received
October 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vibrator, Therapeutic
Device Class
Class I
Regulation Number
890.5975
Review Panel
PM
Submission Type

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  • K931638 — FO96 HANDY MASSAGER (March 28, 1994)
  • K931640 — AO11 BODY MASSAGER (March 28, 1994)
  • K920644 — F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND (May 29, 1992)
  • K914829 — FO92 SEATING MASSAGER (December 9, 1991)
  • K914830 — A101 LITESSAGER (December 9, 1991)
  • K914706 — FO51/F151 GOLF MASSAGER (December 9, 1991)
  • K914704 — FO69 FANCY MASSAGER (December 9, 1991)

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