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510(k) K780085

CANE/REACHER by Fred Sammons, Inc. — Product Code IPS

K780085 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "CANE/REACHER". The FDA issued a decision of Substantially Equivalent on January 30, 1978. The device falls under product code IPS (Cane), a Class I device regulated under 21 CFR 890.3075. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1978
Date Received
January 16, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cane
Device Class
Class I
Regulation Number
890.3075
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)
  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (June 24, 1983)
  • K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (June 24, 1983)
  • K831550 — FINGER BONIOMETER BK7506 (June 24, 1983)
  • K831553 — LEG DRAINAGE BAG STRAP BK6011 (June 16, 1983)
  • K831540 — COMPRESSOGRIP ELASTIC STUMP SHRINKER# (June 8, 1983)

Other clearances for product code IPS

  • K832970 — CANE REACHER (September 29, 1983)
  • K832969 — WALKING CANE (September 29, 1983)
  • K821402 — LIGHT WEIGHT ALUMINUM CANES (April 21, 1982)
  • K790558 — CERSA-CANE (April 3, 1979)
  • K790561 — OFFSET ALUMINUM CANE (April 3, 1979)
  • K790299 — FOREARM-CANE (February 21, 1979)
  • K772267 — QUADRAPLEGIC WALKING AID (December 20, 1977)
  • K770529 — UNICET I (April 5, 1977)

FDA data resources