The following data is part of a premarket notification filed by Lee-meredith Industries, Inc. with the FDA for Orbiter(tm) Treadmill.
Device ID | K897179 |
510k Number | K897179 |
Device Name: | ORBITER(TM) TREADMILL |
Classification | Treadmill, Powered |
Applicant | LEE-MEREDITH INDUSTRIES, INC. 6304 ALDER Houston, TX 77081 |
Contact | Clayton Lee |
Correspondent | Clayton Lee LEE-MEREDITH INDUSTRIES, INC. 6304 ALDER Houston, TX 77081 |
Product Code | IOL |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-28 |
Decision Date | 1990-02-15 |