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510(k) K964933

MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) by Mekanika, Inc. — Product Code LBB

K964933 is an FDA 510(k) premarket notification submitted by Mekanika, Inc. for the device "MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)". The FDA issued a decision of Substantially Equivalent on February 3, 1997. The device falls under product code LBB (Dynamometer, Ac-Powered), a Class II device regulated under 21 CFR 888.1240.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1997
Date Received
December 10, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dynamometer, Ac-Powered
Device Class
Class II
Regulation Number
888.1240
Review Panel
NE
Submission Type

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  • K012492 — KADANCE 2000 (November 2, 2001)
  • K981730 — DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 (July 17, 1998)
  • K980363 — ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) (April 16, 1998)
  • K964685 — DYNAMOMETER (January 27, 1997)
  • K935757 — GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM (April 15, 1994)
  • K931321 — CSD 200/300/400/500 DYNAMOMETER (February 15, 1994)

FDA data resources