The following data is part of a premarket notification filed by Physio Technology, Inc. with the FDA for G5 Apparatus T, K1, K3 & The President Model's.
Device ID | K850851 |
510k Number | K850851 |
Device Name: | G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S |
Classification | Massager, Therapeutic, Electric |
Applicant | PHYSIO TECHNOLOGY, INC. 1925 W. 6TH ST. Topeka, KS 66606 |
Contact | James G Baumann |
Correspondent | James G Baumann PHYSIO TECHNOLOGY, INC. 1925 W. 6TH ST. Topeka, KS 66606 |
Product Code | ISA |
CFR Regulation Number | 890.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-01 |
Decision Date | 1985-06-25 |