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510(k) K923238

SONASSAGE by Conair Corp. — Product Code IRO

K923238 is an FDA 510(k) premarket notification submitted by Conair Corp. for the device "SONASSAGE". The FDA issued a decision of Substantially Equivalent on February 2, 1994. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975. Conair Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1994
Date Received
July 2, 1992
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 Conair Corp.

  • K950441 — CONAIR FAMILY FITNESS BODY ENERGY (July 18, 1995)
  • K950410 — CONAIR BODY AND SOLE (May 23, 1995)
  • K944637 — FAMILY FITNESS SHIATSU MASSAGER (December 13, 1994)
  • K943730 — SQUEEZE PLAY (November 28, 1994)
  • K924970 — FEMININE HEAT WRAP (October 3, 1994)
  • K943092 — FAMILY FITNESS SHIATSU MASSAGER (September 29, 1994)
  • K942950 — BODY FLEX (July 26, 1994)
  • K942223 — BODY SYSTEM (June 9, 1994)
  • K940369 — BODY RECHARGER (April 21, 1994)
  • K926339 — BODY RELAXER (March 4, 1994)

Other clearances for product code IRO

  • K955160 — COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER (February 8, 1996)
  • K955250 — QI GONG 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