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510(k) K926262

FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE by Sgarlato Laboratories, Inc. — Product Code BXB

K926262 is an FDA 510(k) premarket notification submitted by Sgarlato Laboratories, Inc. for the device "FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE". The FDA issued a decision of Substantially Equivalent on January 26, 1994. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Sgarlato Laboratories, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1994
Date Received
December 18, 1992
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 Sgarlato Laboratories, Inc.

  • K043204 — SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP (March 30, 2005)
  • K990101 — PAIN CONTROL INFUSION PUMP (March 19, 1999)
  • K982931 — THREADED FIXATION PIN (October 21, 1998)
  • K926237 — O'BRIEN GONIOMETER (August 2, 1993)
  • K922292 — LUNDEEN SUBTALAR PEG IMPLANT (October 23, 1992)
  • K905795 — SGARLATO FLEXIBLE HINGE TOE IMPLANT (May 29, 1991)
  • K884739 — SGARLATO LESSER TOE IMPLANT (May 18, 1989)

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)
  • K955106 — BTE CPM-20 (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