IME · Pack, Hot Or Cold, Reusable
Physical Medicine · 21 CFR 890.5700 · Class 1
Overview
| Product Code | IME |
|---|---|
| Device Name | Pack, Hot Or Cold, Reusable |
| Regulation | 21 CFR 890.5700 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A cold pack is a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated pliable silicate gel capable of forming to the contour of the body and that provides cold therapy for body surfaces.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K923627 | COLD PACK | Friendmed Products | Apr 14, 1993 | SESE |
| K915876 | HOTPAD | Ten Comfort Corp. | Feb 12, 1993 | SESE |
| K921446 | HOT OR COLD PACK (THERMIPAQ) | Thermionics Corp. | Jul 13, 1992 | SESE |
| K905207 | MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS | Micro Surgical Instruments Corp. | Jan 22, 1991 | SN |
| K882413 | SUBOCCIPITAL ICE PILLOW | Ferguson Medical | Nov 30, 1988 | SESE |
| K863654 | RE-HEATER, HOT PACK | K & L Ent. | Oct 23, 1986 | SESE |
| K832193 | NICE PACK | Universal Medical Instrument Corp. | Aug 31, 1983 | SESE |
| K831899 | ENSWELL | Dr. Micheal A. Sabia | Jul 7, 1983 | SESE |
| K830981 | MICROPAK MOIST HEAT PAD | Micropak Manufacturers, Inc. | Jun 3, 1983 | SESE |
| K830416 | ICY COLD ICE CAP | Ladora Ent. | Mar 10, 1983 | SESE |
| K823650 | THERMOELASTOMER HOT/COLD COMPRESS-7187- | Fred Sammons, Inc. | Jan 21, 1983 | SESE |
| K823649 | THERMOELASTOMER HOT/COLD COMPRESS BK7186 | Fred Sammons, Inc. | Jan 21, 1983 | SESE |
| K823814 | HOT/COLD PACK HOLDERS | Danek Medical, Inc. | Jan 14, 1983 | SESE |
| K822783 | FLEX ICE FREEZE PACK | Igloo Corp. | Oct 6, 1982 | SESE |
| K821636 | ATTACH-A-PAK | Fred Sammons, Inc. | Jun 11, 1982 | SESE |
| K820901 | COLD ROLL | North Bank Labs, Inc. | Apr 15, 1982 | SESE |
| K820068 | COLD-HOT PACK | Hospital Marketing Services Co., Inc. | Jan 28, 1982 | SESE |
| K810451 | REUSEABLE HOT & COLD PACKS | Fred Sammons, Inc. | Mar 4, 1981 | SESE |
| K810402 | ACE COLD BANDAGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 4, 1981 | SESE |
| K803299 | COLD/HOT PACK | W.G. Whitney Corp. | Jan 15, 1981 | SESE |
Top Applicants
- Fred Sammons, Inc. — 4 clearances
- Ackrad Laboratories — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Danek Medical, Inc. — 1 clearance
- Delta Medical Industries — 1 clearance
