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510(k) K936148

STRESS HANDLER by Arocep Enterprises , Ltd. — Product Code LYG

K936148 is an FDA 510(k) premarket notification submitted by Arocep Enterprises , Ltd. for the device "STRESS HANDLER". The FDA issued a decision of SN on April 21, 1994. The device falls under product code LYG (Massager, Therapeutic, Manual), a Class I device regulated under 21 CFR 890.5660.

Clearance Details

Decision
SN ()
Decision Date
April 21, 1994
Date Received
December 27, 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)
  • K930613 — HOOKING SYSTEM (July 12, 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