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510(k) K955106

BTE CPM-20 by Baltimore Therapeutic Equipment Co. — Product Code BXB

K955106 is an FDA 510(k) premarket notification submitted by Baltimore Therapeutic Equipment Co. for the device "BTE CPM-20". The FDA issued a decision of Substantially Equivalent on December 29, 1995. 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
December 29, 1995
Date Received
November 8, 1995
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.

  • 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)
  • K800007 — WORK SIMULATOR (January 21, 1980)

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)
  • 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)
  • K950682 — W2 WRIST CPM UNIT (September 13, 1995)

FDA data resources