510(k) K952975

ANKLE CALF EXERCISER PHLEBOPUMP by Prevent Products, Inc. — Product Code BXB

K952975 is an FDA 510(k) premarket notification submitted by Prevent Products, Inc. for the device "ANKLE CALF EXERCISER PHLEBOPUMP". The FDA issued a decision of Substantially Equivalent on September 25, 1996. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Prevent Products, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1996
Date Received
June 27, 1995
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