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510(k) K924518

BODY SOOTHER by Conair Corp. — Product Code ISA

K924518 is an FDA 510(k) premarket notification submitted by Conair Corp. for the device "BODY SOOTHER". The FDA issued a decision of Substantially Equivalent on Oct 12, 1993. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660. 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
Massager, Therapeutic, Electric
Device Class
Class I
Regulation Number
890.5660
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 ISA

  • K243488 — VMAT PRO (Feb 6, 2025)
  • K240358 — ShockPhysio Mobile (model SW3200 Basic) (Jun 5, 2024)
  • K221865 — BTL-094 (Apr 14, 2023)
  • K210166 — Omnispec ED1000 (Jan 27, 2023)
  • K213120 — OW100S (model OW100S-US) (Oct 12, 2022)
  • K220538 — DolorClast Radial (Jul 11, 2022)
  • K210451 — OrthoGold 100 (May 5, 2021)
  • K182682 — OrthoGold 100 (Dec 21, 2018)
  • K173692 — D-Actor 200 Vibration Massage System (Apr 13, 2018)
  • K053225 — CELLU M6 KEYMODULE I (Nov 6, 2006)

FDA data resources