INSTANT HOT PACKS
Device Facts
| Record ID | K963768 |
|---|---|
| Device Name | INSTANT HOT PACKS |
| Applicant | Kick Ice, Inc. |
| Product Code | IMD · Physical Medicine |
| Decision Date | Nov 25, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5710 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Intended Use
The device provides instant hot treatment used for first aid purposes to reduce local pain and discomfort.
Device Story
Instant hot pack; provides localized heat therapy for first aid; reduces pain and discomfort; disposable; used in clinical or home settings; operated by patient or caregiver; provides therapeutic heat via chemical reaction; benefits patient through non-invasive pain management.
Clinical Evidence
No clinical data; reliance on 32-year market history of similar hot therapy applications.
Technological Characteristics
Disposable chemical heat pack; 21 CFR 890.5710 classification; non-powered; manual activation.
Indications for Use
Indicated for first aid use to provide localized heat therapy for pain and discomfort relief in general patient populations.
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
- Jack Frost Laboratories Instant Hot Pack
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