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510(k) K924315

THE MASSAGER by Four Directions — Product Code LYG

K924315 is an FDA 510(k) premarket notification submitted by Four Directions for the device "THE MASSAGER". The FDA issued a decision of Substantially Equivalent on October 8, 1993. The device falls under product code LYG (Massager, Therapeutic, Manual), a Class I device regulated under 21 CFR 890.5660.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1993
Date Received
August 26, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Therapeutic, Manual
Device Class
Class I
Regulation Number
890.5660
Review Panel
PM
Submission Type

Other clearances for product code LYG

  • K963704 — MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE (November 26, 1996)
  • K936312 — MANUAL MASSAGE ROLLER (January 29, 1996)
  • K952043 — BACK MASSAGER (September 1, 1995)
  • K930613 — HOOKING SYSTEM (July 12, 1994)
  • K936148 — STRESS HANDLER (April 21, 1994)
  • K922366 — SPINE LINE (July 13, 1992)
  • K915361 — THE BODY BUGGY (December 20, 1991)
  • K912512 — TAICHI STICK MASSAGER (September 6, 1991)
  • K903820 — THERA-CANE (September 19, 1990)
  • K884907 — BUMPY MEDICAL MASSAGE MAT (December 27, 1988)

FDA data resources