The following data is part of a premarket notification filed by Innovative Med, Inc. with the FDA for Innovative Med Multi Wave Light Therapy System.
| Device ID | K093204 |
| 510k Number | K093204 |
| Device Name: | INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | INNOVATIVE MED, INC. 4 AUTRY, UNIT B Irvine, CA 92618 |
| Contact | Jeffrey Kolster |
| Correspondent | Jeffrey Kolster INNOVATIVE MED, INC. 4 AUTRY, UNIT B Irvine, CA 92618 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-13 |
| Decision Date | 2010-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851314007090 | K093204 | 000 |