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 |
Indications for 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
