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510(k) K952163

DAVID BACK CLINIC SYSTEM by Kinetic Resources, Inc. — Product Code ISD

K952163 is an FDA 510(k) premarket notification submitted by Kinetic Resources, Inc. for the device "DAVID BACK CLINIC SYSTEM". The FDA issued a decision of Substantially Equivalent on August 12, 1996. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1996
Date Received
May 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Measuring
Device Class
Class II
Regulation Number
890.5360
Review Panel
PM
Submission Type

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  • K962855 — ULE-2, MULE-2, HAND ACCESSORY KIT (December 11, 1996)
  • K941033 — PHYSIO HAB (February 27, 1995)

FDA data resources