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510(k) K915361

THE BODY BUGGY by Innova Corp. — Product Code LYG

K915361 is an FDA 510(k) premarket notification submitted by Innova Corp. for the device "THE BODY BUGGY". The FDA issued a decision of Substantially Equivalent on December 20, 1991. The device falls under product code LYG (Massager, Therapeutic, Manual), a Class I device regulated under 21 CFR 890.5660. Innova Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1991
Date Received
November 27, 1991
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 Innova Corp.

  • K040714 — HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT (April 9, 2004)
  • K984117 — INNOVA TELESCOPIC DISTRACTOR (February 10, 1999)
  • K971196 — ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM (May 8, 1997)
  • K952434 — ENDOPORE DENTAL IMPLANT ABUTMENTS (July 19, 1995)
  • K926354 — ENDO-PORE ENDOSSEOUS DENTAL IMPLANT SYSTEM (February 13, 1995)

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)
  • K912512 — TAICHI STICK MASSAGER (September 6, 1991)
  • K903820 — THERA-CANE (September 19, 1990)
  • K884907 — BUMPY MEDICAL MASSAGE MAT (December 27, 1988)

FDA data resources