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510(k) K914705

FO41 BODY MASSAGER by Fairform Mfg., Co., Ltd. — Product Code IRO

K914705 is an FDA 510(k) premarket notification submitted by Fairform Mfg., Co., Ltd. for the device "FO41 BODY MASSAGER". The FDA issued a decision of Substantially Equivalent on December 9, 1991. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975. Fairform Mfg., Co., Ltd. has at least 10 other 510(k) clearances on record.

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

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)
  • K920644 — F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND (May 29, 1992)
  • K914706 — FO51/F151 GOLF MASSAGER (December 9, 1991)
  • K914707 — F055 B.O. FANTASTIC RELAXER (December 9, 1991)
  • K914703 — F383 RECHARGEABLE MINI MASSAGER (December 9, 1991)
  • K914829 — FO92 SEATING 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)

FDA data resources