510(k) K871981

BILATERAL CONTINUOUS PASSIVE MOTION DEVICE by Avec Scientific Design Corp. — Product Code BXB

K871981 is an FDA 510(k) premarket notification submitted by Avec Scientific Design Corp. for the device "BILATERAL CONTINUOUS PASSIVE MOTION DEVICE". The FDA issued a decision of Substantially Equivalent on June 17, 1987. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Avec Scientific Design Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1987
Date Received
May 22, 1987
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