The following data is part of a premarket notification filed by General Physiotherapy, Inc. with the FDA for Fleximatic Massager.
Device ID | K852944 |
510k Number | K852944 |
Device Name: | FLEXIMATIC MASSAGER |
Classification | Massager, Therapeutic, Electric |
Applicant | GENERAL PHYSIOTHERAPY, INC. 1520 WASHINGTON AVE. St. Louis, MO 63103 |
Contact | Thomas P Muchisky |
Correspondent | Thomas P Muchisky GENERAL PHYSIOTHERAPY, INC. 1520 WASHINGTON AVE. St. Louis, MO 63103 |
Product Code | ISA |
CFR Regulation Number | 890.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-11 |
Decision Date | 1985-09-05 |