The following data is part of a premarket notification filed by Tri W-g, Inc. with the FDA for R1361 & R1372 Measured Exercise Equipment.
Device ID | K861348 |
510k Number | K861348 |
Device Name: | R1361 & R1372 MEASURED EXERCISE EQUIPMENT |
Classification | Exerciser, Measuring |
Applicant | TRI W-G, INC. P.O. BOX 905 Valley City, ND 58072 |
Contact | John Weber |
Correspondent | John Weber TRI W-G, INC. P.O. BOX 905 Valley City, ND 58072 |
Product Code | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-07 |
Decision Date | 1986-05-02 |