IME — Pack, Hot Or Cold, Reusable Class I
FDA Device Classification
Classification Details
- Product Code
- IME
- Device Class
- Class I
- Regulation Number
- 890.5700
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K923627 | friendmed products | COLD PACK | April 14, 1993 |
| K915876 | ten comfort | HOTPAD | February 12, 1993 |
| K921446 | thermionics | HOT OR COLD PACK (THERMIPAQ) | July 13, 1992 |
| K905207 | micro surgical instruments | MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS | January 22, 1991 |
| K882413 | ferguson medical | SUBOCCIPITAL ICE PILLOW | November 30, 1988 |
| K863654 | k and l ent | RE-HEATER, HOT PACK | October 23, 1986 |
| K832193 | universal medical instrument | NICE PACK | August 31, 1983 |
| K831899 | micheal a. sabia | ENSWELL | July 7, 1983 |
| K830981 | micropak manufacturers | MICROPAK MOIST HEAT PAD | June 3, 1983 |
| K830416 | ladora ent | ICY COLD ICE CAP | March 10, 1983 |
| K823649 | fred sammons | THERMOELASTOMER HOT/COLD COMPRESS BK7186 | January 21, 1983 |
| K823650 | fred sammons | THERMOELASTOMER HOT/COLD COMPRESS-7187- | January 21, 1983 |
| K823814 | danek medical | HOT/COLD PACK HOLDERS | January 14, 1983 |
| K822783 | igloo | FLEX ICE FREEZE PACK | October 6, 1982 |
| K821636 | fred sammons | ATTACH-A-PAK | June 11, 1982 |
| K820901 | north bank labs | COLD ROLL | April 15, 1982 |
| K820068 | hospital marketing services co | COLD-HOT PACK | January 28, 1982 |
| K810451 | fred sammons | REUSEABLE HOT & COLD PACKS | March 4, 1981 |
| K810402 | bd becton dickinson vacutainer systems preanalytic | ACE COLD BANDAGE | March 4, 1981 |
| K803299 | w.g. whitney | COLD/HOT PACK | January 15, 1981 |