Olympic Warm-Up
FDA 510(k) K001056 · Olympic Medical Corp.
510(k) numberK001056
Submission
- Device name
- Olympic Warm-Up
- Applicant
- Olympic Medical Corp.
Seattle, WA, US - Received
- April 3, 2000
- Decision date
- September 29, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ILY – Lamp, Infrared, Therapeutic Heating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
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More from Wellray Medical Laser, Inc.
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|---|---|---|
| K081094 | Olympic Pasteurmatic, Models 3000 and 3500MEC · Special | 06/20/2008SE |
| K031149 | Olympic CFM 6000OMA · Special | 05/14/2003SE |
| K020335 | Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330OMC · Traditional | 06/18/2002SE |
| K983229 | Olympic Medical Lectromed Cerebral Function Monitor SystemOMA · Traditional | 03/23/1999SE |
| K971601 | Olympic Bili-BassinetLBI · Traditional | 09/24/1997SE |
| K972193 | Olympix Mini-Pasteurmatic (58210)LDS · Traditional | 09/05/1997SE |
| K971117 | WarmetteLHC · Traditional | 08/22/1997SE |
| K955357 | Olympic Smart Scale Model 50/50RAFRW · Traditional | 01/30/1996SE |
| K954434 | Olympic Infant ThermometerFLL · Traditional | 12/20/1995SE |
| K955177 | Olympic Smart ScaleFRW · Traditional | 12/14/1995SE |
Questions and answers
When was Olympic Warm-Up cleared by the FDA?
Olympic Warm-Up (K001056) received a 510(k) decision of Substantially Equivalent on September 29, 2000, 179 days after the submission was received.
What is the product code of K001056?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.