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510(k) K884907

BUMPY MEDICAL MASSAGE MAT by Medical Flotation Systems, Inc. — Product Code LYG

K884907 is an FDA 510(k) premarket notification submitted by Medical Flotation Systems, Inc. for the device "BUMPY MEDICAL MASSAGE MAT". The FDA issued a decision of Substantially Equivalent on December 27, 1988. The device falls under product code LYG (Massager, Therapeutic, Manual), a Class I device regulated under 21 CFR 890.5660. Medical Flotation Systems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1988
Date Received
November 23, 1988
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 by Medical Flotation Systems, Inc.

  • K893801 — M.F.S. LOW AIR LOSS PULSATING BED (July 25, 1989)
  • K890200 — PNEUMATIC DORSIFLEXOR (February 3, 1989)
  • K884908 — ULTRAFLOTATION MEDICAL WHEELCHAIR (December 27, 1988)
  • K882607 — ULTRAFLOTATION BED (October 14, 1988)

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)
  • 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)

FDA data resources