Home / 510(k) Clearances / K924519

510(k) K924519

BODYTHERM by Conair Corp. — Product Code IRO

K924519 is an FDA 510(k) premarket notification submitted by Conair Corp. for the device "BODYTHERM". The FDA issued a decision of Substantially Equivalent on Oct 12, 1993. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975. Conair Corp. has 28 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 12, 1993
Date Received
Sep 4, 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
510(k) Exempt

Other clearances by Conair Corp.

  • K950441 — CONAIR FAMILY FITNESS BODY ENERGY (Jul 18, 1995)
  • K950410 — CONAIR BODY AND SOLE (May 23, 1995)
  • K944637 — FAMILY FITNESS SHIATSU MASSAGER (Dec 13, 1994)
  • K943730 — SQUEEZE PLAY (Nov 28, 1994)
  • K924970 — FEMININE HEAT WRAP (Oct 3, 1994)
  • K943092 — FAMILY FITNESS SHIATSU MASSAGER (Sep 29, 1994)
  • K942950 — BODY FLEX (Jul 26, 1994)
  • K942223 — BODY SYSTEM (Jun 9, 1994)
  • K940369 — BODY RECHARGER (Apr 21, 1994)
  • K926339 — BODY RELAXER (Mar 4, 1994)

Other clearances for product code IRO

  • K955250 — QI GONG MASSAGER (Feb 8, 1996)
  • K955160 — COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER (Feb 8, 1996)
  • K954203 — MASSAGER THERAPUTIC, ELECTRIC (Dec 11, 1995)
  • K952916 — SHIATSU MASTER MASSAGER CUSHION (Aug 28, 1995)
  • K951414 — CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR (Aug 11, 1995)
  • K950441 — CONAIR FAMILY FITNESS BODY ENERGY (Jul 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 (Mar 30, 1995)

FDA data resources