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510(k) K951770

BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP by Biodex Medical Systems, Inc. — Product Code IKK

K951770 is an FDA 510(k) premarket notification submitted by Biodex Medical Systems, Inc. for the device "BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP". The FDA issued a decision of Substantially Equivalent on November 16, 1995. The device falls under product code IKK (System, Isokinetic Testing And Evaluation), a Class II device regulated under 21 CFR 890.1925. Biodex Medical Systems, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1995
Date Received
April 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Isokinetic Testing And Evaluation
Device Class
Class II
Regulation Number
890.1925
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)
  • K950981 — ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 (April 3, 1995)
  • K942694 — STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 (March 10, 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 IKK

  • K123746 — AMES THERAPY DEVICE (May 24, 2013)
  • K952090 — HUMAC SYSTEM (December 11, 1995)
  • K951916 — CC RIDER, MODEL ME180 (October 4, 1995)
  • K950095 — CYBEX 770 (June 21, 1995)
  • K942229 — MOTIVATOR FTR 2000 (February 27, 1995)
  • K944732 — DEXTER ISOKINETIC (February 3, 1995)
  • K924414 — THE BTE DYNAMIC LIFT (February 12, 1993)
  • K923350 — CLOSED CHAIN ATTACHMENT, MODEL #820-520 (July 23, 1992)
  • K922772 — TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR (July 13, 1992)
  • K922092 — SINGLE CHAIR INTEGRAL BACK ATTACHMENT (May 26, 1992)

FDA data resources