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510(k) K924414

THE BTE DYNAMIC LIFT by Baltimore Therapeutic Equipment Co. — Product Code IKK

K924414 is an FDA 510(k) premarket notification submitted by Baltimore Therapeutic Equipment Co. for the device "THE BTE DYNAMIC LIFT". The FDA issued a decision of Substantially Equivalent on February 12, 1993. The device falls under product code IKK (System, Isokinetic Testing And Evaluation), a Class II device regulated under 21 CFR 890.1925. Baltimore Therapeutic Equipment Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1993
Date Received
August 31, 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 Baltimore Therapeutic Equipment Co.

  • K955106 — BTE CPM-20 (December 29, 1995)
  • K955105 — BTE CPM-10 (December 29, 1995)
  • K925225 — THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK (June 27, 1994)
  • K933611 — THE BTE WS30 (June 20, 1994)
  • K895881 — MOTIONSPECT (April 10, 1990)
  • K800007 — WORK SIMULATOR (January 21, 1980)

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)
  • 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