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510(k) K922092

SINGLE CHAIR INTEGRAL BACK ATTACHMENT by Biodan Medical Systems, Ltd. — Product Code IKK

K922092 is an FDA 510(k) premarket notification submitted by Biodan Medical Systems, Ltd. for the device "SINGLE CHAIR INTEGRAL BACK ATTACHMENT". The FDA issued a decision of Substantially Equivalent on May 26, 1992. The device falls under product code IKK (System, Isokinetic Testing And Evaluation), a Class II device regulated under 21 CFR 890.1925. Biodan Medical Systems, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1992
Date Received
May 5, 1992
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 Biodan Medical Systems, Ltd.

  • K932153 — THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME (September 7, 1993)
  • K930261 — RTM REHABILITATION TREADMILL, MODEL #945-200 (May 26, 1993)
  • K930262 — TREATMENT TABLE, MODEL #825-100 (March 29, 1993)
  • K930259 — TRACTION TABLE MODEL #825-200 (March 24, 1993)
  • K926083 — NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES (February 12, 1993)
  • K926082 — CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT (December 30, 1992)
  • K922591 — UROLOGICAL C-ARM TABLE, MODEL #056-450 (November 27, 1992)
  • K922604 — DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE (October 20, 1992)
  • K922605 — TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603 (October 20, 1992)
  • K923350 — CLOSED CHAIN ATTACHMENT, MODEL #820-520 (July 23, 1992)

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