The following data is part of a premarket notification filed by Medical Science Technology, Inc. with the FDA for Cool/heat Therapy Applicator.
| Device ID | K944447 |
| 510k Number | K944447 |
| Device Name: | COOL/HEAT THERAPY APPLICATOR |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | MEDICAL SCIENCE TECHNOLOGY, INC. 1810 STAFFORD AVE. Fredericksburg, VA 22401 |
| Contact | Stuart Horn |
| Correspondent | Stuart Horn MEDICAL SCIENCE TECHNOLOGY, INC. 1810 STAFFORD AVE. Fredericksburg, VA 22401 |
| 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 | 1994-09-12 |
| Decision Date | 1995-02-09 |