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510(k) K936312

MANUAL MASSAGE ROLLER by Mckenna & Cuneo — Product Code LYG

K936312 is an FDA 510(k) premarket notification submitted by Mckenna & Cuneo for the device "MANUAL MASSAGE ROLLER". The FDA issued a decision of SN on January 29, 1996. The device falls under product code LYG (Massager, Therapeutic, Manual), a Class I device regulated under 21 CFR 890.5660. Mckenna & Cuneo has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
January 29, 1996
Date Received
November 26, 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 by Mckenna & Cuneo

  • K971257 — VTU-1 VACUUM ERECTION SYSTEM (October 3, 1997)
  • K944547 — DANTEC KEYPOINT (September 19, 1995)

Other clearances for product code LYG

  • K963704 — MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE (November 26, 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)
  • K884907 — BUMPY MEDICAL MASSAGE MAT (December 27, 1988)

FDA data resources