The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympic Warm-up.
| Device ID | K001056 |
| 510k Number | K001056 |
| Device Name: | OLYMPIC WARM-UP |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Contact | Joseph P Stefanile |
| Correspondent | Joseph P Stefanile OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-03 |
| Decision Date | 2000-09-29 |