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510(k) K823620

PLASTIC ELASTOMER IN CUBE FORM EXERCISE by Fred Sammons, Inc. — Product Code ION

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1982
Date Received
December 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Non-Measuring
Device Class
Class I
Regulation Number
890.5370
Review Panel
PM
Submission Type

Other clearances by Fred Sammons, Inc.

  • K880644 — ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) (May 6, 1988)
  • K880647 — ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) (April 1, 1988)
  • K831549 — ARM SLINGS (June 30, 1983)
  • K831548 — SPLINTS (June 27, 1983)
  • K831544 — DELUXE TRACTION EXERCISE GLOVE BK5035 (June 24, 1983)
  • K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (June 24, 1983)
  • K831550 — FINGER BONIOMETER BK7506 (June 24, 1983)
  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (June 24, 1983)
  • K831553 — LEG DRAINAGE BAG STRAP BK6011 (June 16, 1983)
  • K831547 — RAISED TOILET SEATS & NAIL CLIPPERS (June 8, 1983)

Other clearances for product code ION

  • K120783 — ABLE-X (June 20, 2012)
  • K885343 — STANDEX (May 1, 1989)
  • K851065 — GRAVITY KING (DEEMED SE 87/09/18) (June 13, 1985)
  • K840551 — MOBILIZER (March 23, 1984)
  • K833870 — KNEE WALKER (November 29, 1983)
  • K833249 — FITNESS (November 7, 1983)
  • K832968 — PEDAL EXERCISER (September 29, 1983)
  • K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (June 24, 1983)
  • K831538 — DELUXE ADJUST-ANGLE BOARD-BK4066 (June 8, 1983)
  • K831033 — GIREX (April 27, 1983)