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510(k) K952043

BACK MASSAGER by Eight Corners, Inc. — Product Code LYG

K952043 is an FDA 510(k) premarket notification submitted by Eight Corners, Inc. for the device "BACK MASSAGER". The FDA issued a decision of Substantially Equivalent on September 1, 1995. 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
September 1, 1995
Date Received
May 1, 1995
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)
  • K930613 — HOOKING SYSTEM (July 12, 1994)
  • K936148 — STRESS HANDLER (April 21, 1994)
  • K924315 — THE MASSAGER (October 8, 1993)
  • 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