IMD · Pack, Hot Or Cold, Disposable
Physical Medicine · 21 CFR 890.5710 · Class 1
Overview
| Product Code | IMD |
|---|---|
| Device Name | Pack, Hot Or Cold, Disposable |
| Regulation | 21 CFR 890.5710 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.
Classification Rationale
Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Recent Cleared Devices (20 of 82)
Showing 20 most recent of 82 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221653 | InfaTherm Disposable Infant Warming Mattress | International Biomedical | Oct 6, 2022 | SESE |
| K163295 | Infant Transport Mattress Warmer with Disc | Rapid Aid Corp. | Jul 24, 2017 | SESE |
| K112547 | NEO NEST | Denovo Proucts, LLC | Mar 6, 2012 | SESE |
| K082087 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | Sep 11, 2008 | SESE |
| K071710 | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) | Johnson & Johnson Consumer Products, Inc. | Aug 14, 2007 | SESE |
| K021843 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | Sep 3, 2002 | SESE |
| K982652 | ALLEGIANCE PORTA-WARM MATTRESS | Allegiance Healthcare Corp. | Jan 21, 1999 | SESE |
| K980509 | DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS | Deroyal Industries, Inc. | Feb 26, 1998 | SESE |
| K974190 | CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER | Consolidated Products & Services, Inc. | Nov 19, 1997 | SESE |
| K973770 | ALLEGIANCE KWIK HEAT WARM PERINEAL PACK | Allegiance Healthcare Corp. | Nov 13, 1997 | SESE |
| K970399 | KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) | Allegiance Healthcare Corp. | Apr 3, 1997 | SESE |
| K963689 | RECOVER ADULT VEIN WARMER | Florida Medical Industries, Inc. | Dec 12, 1996 | SESE |
| K963768 | INSTANT HOT PACKS | Kick Ice, Inc. | Nov 25, 1996 | SESE |
| K963666 | INSTANT COLD PACK | Kick Ice, Inc. | Oct 30, 1996 | SESE |
| K963220 | TEMPRA COLD PACK, REORDER NO. TC150 | Tempo Technology, Inc. | Oct 10, 1996 | SESE |
| K961176 | OMNI COLD GEL PACKS | Omni Therm, Inc. | Sep 4, 1996 | SESE |
| K955788 | IMNI HOT PACKS | Omni Therm, Inc. | Sep 4, 1996 | SESE |
| K951033 | ANDELA DYNAMIC COOLING DEVICE | Candela Laser Corp. | Aug 15, 1996 | SESE |
| K960624 | CERTI COOL INSTANT COLD COMPRESS | Certified Safety Mfg., Inc. | May 6, 1996 | SN |
| K954877 | OMNI COLD GEL PACKS | Omni Therm, Inc. | Feb 13, 1996 | SN |
Top Applicants
- Omni Therm, Inc. — 4 clearances
- Prism Technologies, Inc. — 4 clearances
- Allegiance Healthcare Corp. — 3 clearances
- Anago, Inc. — 3 clearances
- Consolidated Products & Services, Inc. — 3 clearances
