The following data is part of a premarket notification filed by Innovation Sports, Inc. with the FDA for Thera Cool Home Unit/coolpac(ambu/reservior Units).
| Device ID | K940858 |
| 510k Number | K940858 |
| Device Name: | THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | INNOVATION SPORTS, INC. #7 CHRYSLER Irvine, CA 92718 |
| Contact | Terry L Shirley |
| Correspondent | Terry L Shirley INNOVATION SPORTS, INC. #7 CHRYSLER Irvine, CA 92718 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-23 |
| Decision Date | 1994-07-12 |