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510(k) K831544

DELUXE TRACTION EXERCISE GLOVE BK5035 by Fred Sammons, Inc. — Product Code IOD

K831544 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "DELUXE TRACTION EXERCISE GLOVE BK5035". The FDA issued a decision of Substantially Equivalent on June 24, 1983. The device falls under product code IOD (Components, Exercise), a Class I device regulated under 21 CFR 890.5350. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1983
Date Received
May 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Components, Exercise
Device Class
Class I
Regulation Number
890.5350
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)
  • K831550 — FINGER BONIOMETER BK7506 (June 24, 1983)
  • K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (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)
  • K831552 — SORBOTHANE VISCO INNER SOLE PAD (June 8, 1983)

Other clearances for product code IOD

  • K823648 — SURGICAL TUBING (January 21, 1983)
  • K823822 — ANKLE WEIGHTS (January 14, 1983)
  • K823600 — SOLID WOOD CONE (December 22, 1982)
  • K813632 — COLOR CODED WEIGHT CUFFS (January 19, 1982)
  • K812319 — THERAPY BENCH (August 31, 1981)
  • K790587 — CANVAS WEDGE (April 3, 1979)
  • K772414 — SANDBAGS, VARIOUS WEIGHTS (February 1, 1978)
  • K771030 — FLEXION MITTENS (June 27, 1977)
  • K761119 — SHEET METAL CLAMP (December 2, 1976)
  • K761118 — HAND SCREW CLAMP (December 2, 1976)

FDA data resources