510(k) K910055

ACME MODEL 8500 WHEELCHAIR SCALE by Acme Medical Scale Co. — Product Code INF

K910055 is an FDA 510(k) premarket notification submitted by Acme Medical Scale Co. for the device "ACME MODEL 8500 WHEELCHAIR SCALE". The FDA issued a decision of Substantially Equivalent on January 14, 1991. The device falls under product code INF (Scale, Platform, Wheelchair), a Class I device regulated under 21 CFR 890.3940. Acme Medical Scale Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1991
Date Received
January 7, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scale, Platform, Wheelchair
Device Class
Class I
Regulation Number
890.3940
Review Panel
PM
Submission Type