INSTANT COLD PACK
Device Facts
| Record ID | K963666 |
|---|---|
| Device Name | INSTANT COLD PACK |
| Applicant | Kick Ice, Inc. |
| Product Code | IMD · Physical Medicine |
| Decision Date | Oct 30, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5710 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Intended Use
The device provides instant cold treatment used for first aid purposes to reduce minor local pain, swelling and discomfort.
Device Story
Instant cold pack; consists of outer bag containing Ammonium Nitrate and inner bubble containing water; manual pressure applied to outer bag ruptures inner bubble; endothermic chemical reaction between Ammonium Nitrate and water produces cold; used for first aid; provides localized cold therapy to reduce pain, swelling, and discomfort.
Clinical Evidence
Bench testing only.
Technological Characteristics
Materials: polyester or laminated polyethylene bag; contents: Ammonium Nitrate and water; principle: endothermic chemical reaction; form factor: disposable pack.
Indications for Use
Indicated for first aid use to reduce minor local pain, swelling, and discomfort in patients requiring cold therapy.
Regulatory Classification
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.
Predicate Devices
- ACE Brand Instant Cold Pack (3M)
- Jack Frost
Related Devices
- K960624 — CERTI COOL INSTANT COLD COMPRESS · Certified Safety Mfg., Inc. · May 6, 1996
- K963768 — INSTANT HOT PACKS · Kick Ice, Inc. · Nov 25, 1996
- K982652 — ALLEGIANCE PORTA-WARM MATTRESS · Allegiance Healthcare Corp. · Jan 21, 1999
- K970399 — KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) · Allegiance Healthcare Corp. · Apr 3, 1997
- K974190 — CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER · Consolidated Products & Services, Inc. · Nov 19, 1997
