The following data is part of a premarket notification filed by Pacer Industries, Inc. with the FDA for Pacer R 9 Treadmill.
Device ID | K893032 |
510k Number | K893032 |
Device Name: | PACER R 9 TREADMILL |
Classification | Treadmill, Powered |
Applicant | PACER INDUSTRIES, INC. 1121 CROWLEY RD. Carrollton, TX 75006 |
Contact | Robert Parker |
Correspondent | Robert Parker PACER INDUSTRIES, INC. 1121 CROWLEY RD. Carrollton, TX 75006 |
Product Code | IOL |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-24 |
Decision Date | 1989-07-27 |