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 |