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510(k) K871557

DISCIPLINE II RTD by Physio Systems, Inc. — Product Code IKK

K871557 is an FDA 510(k) premarket notification submitted by Physio Systems, Inc. for the device "DISCIPLINE II RTD". The FDA issued a decision of Substantially Equivalent on August 26, 1987. The device falls under product code IKK (System, Isokinetic Testing And Evaluation), a Class II device regulated under 21 CFR 890.1925. Physio Systems, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1987
Date Received
April 22, 1987
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 Physio Systems, Inc.

  • K910712 — VILLAN (VIDEO LIFT LINK ANALYSIS) (May 21, 1991)
  • K870872 — DISCIPLINE I (March 23, 1987)

Other clearances for product code IKK

  • K123746 — AMES THERAPY DEVICE (May 24, 2013)
  • K952090 — HUMAC SYSTEM (December 11, 1995)
  • K951770 — BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP (November 16, 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)

FDA data resources