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510(k) K962855

ULE-2, MULE-2, HAND ACCESSORY KIT by Penny and Giles Biometrics , Ltd. — Product Code ISD

K962855 is an FDA 510(k) premarket notification submitted by Penny and Giles Biometrics , Ltd. for the device "ULE-2, MULE-2, HAND ACCESSORY KIT". The FDA issued a decision of Substantially Equivalent on December 11, 1996. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360. Penny and Giles Biometrics , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1996
Date Received
July 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Measuring
Device Class
Class II
Regulation Number
890.5360
Review Panel
PM
Submission Type

Other clearances by Penny and Giles Biometrics , Ltd.

  • K934238 — MULE (October 26, 1994)
  • K924416 — BOOST, MICE, GAMESYS. (June 15, 1993)

Other clearances for product code ISD

  • K202979 — MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Do (December 21, 2020)
  • K183296 — REAL Immersive System (March 18, 2019)
  • K143512 — ActiSpec Activity Monitor (August 26, 2015)
  • K112121 — ERGOSELECT/GE (October 31, 2012)
  • K080545 — ACTITRAINER (July 24, 2008)
  • K053078 — ERGOSELECT 100 K/P, ERGOSELECT 200 K/P (April 27, 2006)
  • K990866 — QUINTON MEDTRACK CR PLUS TREADMILL (April 29, 1999)
  • K990813 — REHCOR (April 12, 1999)
  • K952163 — DAVID BACK CLINIC SYSTEM (August 12, 1996)
  • K941033 — PHYSIO HAB (February 27, 1995)

FDA data resources