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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 October 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1993
Date Received
September 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

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 ISA

  • K243488 — VMAT PRO (February 6, 2025)
  • K240358 — ShockPhysio Mobile (model SW3200 Basic) (June 5, 2024)
  • K221865 — BTL-094 (April 14, 2023)
  • K210166 — Omnispec ED1000 (January 27, 2023)
  • K213120 — OW100S (model OW100S-US) (October 12, 2022)
  • K220538 — DolorClast Radial (July 11, 2022)
  • K210451 — OrthoGold 100 (May 5, 2021)
  • K182682 — OrthoGold 100 (December 21, 2018)
  • K173692 — D-Actor 200 Vibration Massage System (April 13, 2018)
  • K053225 — CELLU M6 KEYMODULE I (November 6, 2006)

FDA data resources