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510(k) K931640

AO11 BODY MASSAGER by Fairform Mfg., Co., Ltd. — Product Code IRO

K931640 is an FDA 510(k) premarket notification submitted by Fairform Mfg., Co., Ltd. for the device "AO11 BODY MASSAGER". The FDA issued a decision of Substantially Equivalent on March 28, 1994. 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
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.

  • K931639 — F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR (March 28, 1994)
  • K931636 — FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER (March 28, 1994)
  • K931638 — FO96 HANDY MASSAGER (March 28, 1994)
  • K931637 — A013 FEMI-FORM FACIAL MASSAGER (March 28, 1994)
  • K920644 — F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND (May 29, 1992)
  • K914830 — A101 LITESSAGER (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)
  • 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