Cleared Traditional

K781198 - BOARD, SCOOTER
(FDA 510(k) Clearance)

K781198 · Fred Sammons, Inc. · Physical Medicine device

Jul 1978

Decision

17d

Days

Class 1

Risk

K781198 is an FDA 510(k) clearance for the BOARD, SCOOTER. This device is classified as a Board, Scooter, Prone (Class I - General Controls, product code KNL).

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 31, 1978, 17 days after receiving the submission on July 14, 1978.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5370.

Submission Details

510(k) Number	K781198 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 14, 1978
Decision Date	July 31, 1978
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—