Cleared Traditional

K852278 - ACME(BRAND) LOW-PROFILE WHEELCHAIR SCALE, 17400
(FDA 510(k) Clearance)

Jun 1985
Decision
9d
Days
Class 1
Risk

K852278 is an FDA 510(k) clearance for the ACME(BRAND) LOW-PROFILE WHEELCHAIR SCALE, 17400. This device is classified as a Scale, Patient (Class I - General Controls, product code FRW).

Submitted by Acme Medical Scale Co. (San Leandro, US). The FDA issued a Cleared decision on June 7, 1985, 9 days after receiving the submission on May 29, 1985.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2720.

Submission Details

510(k) Number K852278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1985
Decision Date June 07, 1985
Days to Decision 9 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code FRW — Scale, Patient
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.2720