The following data is part of a premarket notification filed by Prevent Products, Inc. with the FDA for Ankle Calf Exerciser Phlebopump.
Device ID | K952975 |
510k Number | K952975 |
Device Name: | ANKLE CALF EXERCISER PHLEBOPUMP |
Classification | Exerciser, Powered |
Applicant | PREVENT PRODUCTS, INC. 1167 OTTAWA AVE. W St Paul, MN 55118 |
Contact | Carol Garcia |
Correspondent | Carol Garcia PREVENT PRODUCTS, INC. 1167 OTTAWA AVE. W St Paul, MN 55118 |
Product Code | BXB |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-27 |
Decision Date | 1996-09-25 |
Summary: | summary |