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510(k) K942694

STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 by Biodex Medical Systems, Inc. — Product Code KHX

K942694 is an FDA 510(k) premarket notification submitted by Biodex Medical Systems, Inc. for the device "STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302". The FDA issued a decision of Substantially Equivalent on March 10, 1995. The device falls under product code KHX (Platform, Force-Measuring), a Class I device regulated under 21 CFR 890.1575. Biodex Medical Systems, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1995
Date Received
June 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Platform, Force-Measuring
Device Class
Class I
Regulation Number
890.1575
Review Panel
PM
Submission Type

Other clearances by Biodex Medical Systems, Inc.

  • K090296 — ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 A (February 19, 2009)
  • K063666 — SHARPS CONTAINER, MODEL 039-413 (January 25, 2007)
  • K951770 — BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP (November 16, 1995)
  • K950981 — ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 (April 3, 1995)
  • K940301 — COMPEX 2 (December 28, 1994)
  • K935216 — SEMI-RECUMBENT CYCLES (September 16, 1994)
  • K935061 — LOWER BODY CYCLES (September 16, 1994)
  • K935520 — UPPER BODY CYCLES (110 VOLT)/(220 VOLT) (September 16, 1994)

Other clearances for product code KHX

  • K951771 — COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM (August 11, 1995)
  • K946229 — BALANCE MANAGER (August 4, 1995)
  • K930089 — SMS BALANCE PERFORMANCE MONITOR (June 8, 1993)
  • K921340 — FORCE MEASURING PLATFORM (May 26, 1992)
  • K901069 — COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEM (March 16, 1990)
  • K893254 — DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER (January 2, 1990)
  • K883131 — BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000 (October 24, 1988)
  • K883198 — BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM (October 24, 1988)
  • K883130 — BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 2000 (October 24, 1988)
  • K883129 — BIOMECHANICS FORCE PLATFORM/#OR 6-6-1000 & 2000 (October 24, 1988)

FDA data resources