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510(k) K931637

A013 FEMI-FORM FACIAL MASSAGER by Fairform Mfg., Co., Ltd. — Product Code IRO

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

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

  • K931636 — FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER (March 28, 1994)
  • K931638 — FO96 HANDY MASSAGER (March 28, 1994)
  • K931639 — F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR (March 28, 1994)
  • K931640 — AO11 BODY MASSAGER (March 28, 1994)
  • K920644 — F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND (May 29, 1992)
  • K914703 — F383 RECHARGEABLE MINI MASSAGER (December 9, 1991)
  • K914829 — FO92 SEATING MASSAGER (December 9, 1991)
  • K914707 — F055 B.O. FANTASTIC RELAXER (December 9, 1991)
  • K914830 — A101 LITESSAGER (December 9, 1991)
  • K914706 — FO51/F151 GOLF MASSAGER (December 9, 1991)

Other clearances for product code IRO

  • K955250 — QI GONG MASSAGER (February 8, 1996)
  • K955160 — COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER (February 8, 1996)
  • K954203 — MASSAGER THERAPUTIC, ELECTRIC (December 11, 1995)
  • K952916 — SHIATSU MASTER MASSAGER CUSHION (August 28, 1995)
  • K951414 — CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR (August 11, 1995)
  • K950441 — CONAIR FAMILY FITNESS BODY ENERGY (July 18, 1995)
  • K946382 — SKALPI 3200 (May 30, 1995)
  • K950410 — CONAIR BODY AND SOLE (May 23, 1995)
  • K944909 — WAHL FRESH FACE (May 8, 1995)
  • K950400 — HAND MASSAGE UNIT (March 30, 1995)