510(k) K922493

AMERICAN MEDICAL MFG. LUMBAR CPM by American Medical Corp. — Product Code BXB

K922493 is an FDA 510(k) premarket notification submitted by American Medical Corp. for the device "AMERICAN MEDICAL MFG. LUMBAR CPM". The FDA issued a decision of Substantially Equivalent on July 27, 1992. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. American Medical Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1992
Date Received
May 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type