Home / 510(k) Clearances / K861632

510(k) K861632

SIMS CHAIR by Twin City Surgical, Inc. — Product Code IKK

K861632 is an FDA 510(k) premarket notification submitted by Twin City Surgical, Inc. for the device "SIMS CHAIR". The FDA issued a decision of Substantially Equivalent on May 27, 1986. The device falls under product code IKK (System, Isokinetic Testing And Evaluation), a Class II device regulated under 21 CFR 890.1925. Twin City Surgical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1986
Date Received
April 29, 1986
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 Twin City Surgical, Inc.

  • K870767 — THE (CROM) TESTER (March 17, 1987)
  • K830585 — ANVIL RETRACTOR (May 27, 1983)
  • K820659 — A CALIPER (March 19, 1982)
  • K820660 — A HOOK DRIVER (March 19, 1982)
  • K813067 — SPINAL WRENCH (November 24, 1981)

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