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510(k) K880644

ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) by Fred Sammons, Inc. — Product Code IRQ

K880644 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)". The FDA issued a decision of Substantially Equivalent on May 6, 1988. The device falls under product code IRQ (Unit, Heating, Powered), a Class I device regulated under 21 CFR 890.5950. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1988
Date Received
February 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Heating, Powered
Device Class
Class I
Regulation Number
890.5950
Review Panel
PM
Submission Type

Other clearances by Fred Sammons, Inc.

  • 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)
  • K831544 — DELUXE TRACTION EXERCISE GLOVE BK5035 (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)
  • K831540 — COMPRESSOGRIP ELASTIC STUMP SHRINKER# (June 8, 1983)
  • K831552 — SORBOTHANE VISCO INNER SOLE PAD (June 8, 1983)

Other clearances for product code IRQ

  • K050524 — EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 (September 14, 2005)
  • K950350 — THEMALATOR. MODELS T-4-S, T-8-S, ETC. (March 24, 1995)
  • K924023 — FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 (April 14, 1993)
  • K861340 — R1750 AND R1424 POWERED HEATING UNITS (May 2, 1986)
  • K832177 — PULSAIR MODEL SP-1 (December 9, 1983)
  • K801625 — THERMOLATOR HEATING UNIT (July 28, 1980)

FDA data resources