Cleared Traditional

K780085 - CANE/REACHER
(FDA 510(k) Clearance)

Jan 1978
Decision
14d
Days
Class 1
Risk

K780085 is an FDA 510(k) clearance for the CANE/REACHER. This device is classified as a Cane (Class I - General Controls, product code IPS).

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1978, 14 days after receiving the submission on January 16, 1978.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3075.

Submission Details

510(k) Number K780085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1978
Decision Date January 30, 1978
Days to Decision 14 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code IPS — Cane
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.3075