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510(k) K925225

THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK by Baltimore Therapeutic Equipment Co. — Product Code KQX

K925225 is an FDA 510(k) premarket notification submitted by Baltimore Therapeutic Equipment Co. for the device "THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK". The FDA issued a decision of Substantially Equivalent on June 27, 1994. The device falls under product code KQX (Goniometer, Ac-Powered), a Class I device regulated under 21 CFR 888.1500. Baltimore Therapeutic Equipment Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1994
Date Received
October 16, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Goniometer, Ac-Powered
Device Class
Class I
Regulation Number
888.1500
Review Panel
NE
Submission Type

Other clearances by Baltimore Therapeutic Equipment Co.

  • K955106 — BTE CPM-20 (December 29, 1995)
  • K955105 — BTE CPM-10 (December 29, 1995)
  • K933611 — THE BTE WS30 (June 20, 1994)
  • K924414 — THE BTE DYNAMIC LIFT (February 12, 1993)
  • K895881 — MOTIONSPECT (April 10, 1990)
  • K800007 — WORK SIMULATOR (January 21, 1980)

Other clearances for product code KQX

  • K011827 — ORTELIUS 800 (August 28, 2001)
  • K971079 — INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE (July 9, 1997)
  • K962377 — 3D-SPINE (September 3, 1996)
  • K961212 — SPINAL TOUCH (June 12, 1996)
  • K954647 — INCLINOMETER (October 30, 1995)
  • K943929 — DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) (May 15, 1995)
  • K945630 — LARGE MUSCLE STRENGTH GAUGE (May 10, 1995)
  • K943898 — SAUNDERS ELECTRONIC INCLINOMETER (November 28, 1994)
  • K940812 — INSIGHT ELECTRONIC ALIGNMENT INDICATOR (November 21, 1994)
  • K933063 — ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA (January 27, 1994)

FDA data resources