The following data is part of a premarket notification filed by Battle Creek Equipment Co. with the FDA for Pulsestar Exercise Bike.
Device ID | K863884 |
510k Number | K863884 |
Device Name: | PULSESTAR EXERCISE BIKE |
Classification | Exerciser, Measuring |
Applicant | BATTLE CREEK EQUIPMENT CO. 307 WEST JACKSON ST. Battle Creek, MI 49017 |
Contact | John W Doty |
Correspondent | John W Doty BATTLE CREEK EQUIPMENT CO. 307 WEST JACKSON ST. Battle Creek, MI 49017 |
Product Code | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-06 |
Decision Date | 1986-10-23 |