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510(k) K930613

HOOKING SYSTEM by Alain Machtelinckx — Product Code LYG

K930613 is an FDA 510(k) premarket notification submitted by Alain Machtelinckx for the device "HOOKING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 12, 1994. 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
July 12, 1994
Date Received
February 5, 1993
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)
  • 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