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510(k) K924315

THE MASSAGER by Four Directions — Product Code LYG

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

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  • 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)