The following data is part of a premarket notification filed by Henley Intl. with the FDA for Stair Climber.
Device ID | K926278 |
510k Number | K926278 |
Device Name: | STAIR CLIMBER |
Classification | Exerciser, Measuring |
Applicant | HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
Contact | Ernest J Henley |
Correspondent | Ernest J Henley HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
Product Code | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-14 |
Decision Date | 1994-05-05 |