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510(k) K800007

WORK SIMULATOR by Baltimore Therapeutic Equipment Co. — Product Code BXB

K800007 is an FDA 510(k) premarket notification submitted by Baltimore Therapeutic Equipment Co. for the device "WORK SIMULATOR". The FDA issued a decision of Substantially Equivalent on January 21, 1980. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Baltimore Therapeutic Equipment Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1980
Date Received
January 3, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Powered
Device Class
Class I
Regulation Number
890.5380
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)
  • K924414 — THE BTE DYNAMIC LIFT (February 12, 1993)
  • K895881 — MOTIONSPECT (April 10, 1990)

Other clearances for product code BXB

  • K072887 — G-TRAINER MEDICAL (January 25, 2008)
  • K003272 — FLO-BOOT (April 4, 2001)
  • K952975 — ANKLE CALF EXERCISER PHLEBOPUMP (September 25, 1996)
  • K953456 — E-Z FLEX (January 26, 1996)
  • K955106 — BTE CPM-20 (December 29, 1995)
  • K955105 — BTE CPM-10 (December 29, 1995)
  • K951028 — HAMEX TWO (December 11, 1995)
  • K950755 — FLEXMATE K500 (October 5, 1995)
  • K951029 — HAMEX ONE (September 15, 1995)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)

FDA data resources