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510(k) K832940

ROTAGYM by I-Rep, Inc. — Product Code ISD

K832940 is an FDA 510(k) premarket notification submitted by I-Rep, Inc. for the device "ROTAGYM". The FDA issued a decision of Substantially Equivalent on November 7, 1983. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360. I-Rep, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1983
Date Received
August 29, 1983
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 I-Rep, Inc.

  • K930692 — LATHAM TABLE (February 2, 1994)
  • K930691 — ACCUTRAC TRACTION UNIT (July 22, 1993)
  • K861864 — MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT (July 14, 1986)
  • K854947 — REHABILITATION TABLES (January 3, 1986)
  • K851690 — ADJUSTABLE TREATMENT TABLES (May 7, 1985)
  • K842268 — VACUPULSE VACUUM UNIT (July 20, 1984)
  • K822906 — PHYSICAL MEDICINE & REHABILITATION EQUIP (October 15, 1982)

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)
  • K962855 — ULE-2, MULE-2, HAND ACCESSORY KIT (December 11, 1996)
  • K952163 — DAVID BACK CLINIC SYSTEM (August 12, 1996)

FDA data resources