The following data is part of a premarket notification filed by Toronto Medical Corp. with the FDA for Dr Kool.
| Device ID | K935841 |
| 510k Number | K935841 |
| Device Name: | DR KOOL |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | TORONTO MEDICAL CORP. 901 DILLINGHAM ROAD PICKERING, ONTARIO Canada L1w 2y5, CA |
| Contact | Barbara Holt |
| Correspondent | Barbara Holt TORONTO MEDICAL CORP. 901 DILLINGHAM ROAD PICKERING, ONTARIO Canada L1w 2y5, CA |
| 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 | 1993-12-07 |
| Decision Date | 1994-08-29 |