(87 days)
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No
The device description and intended use are purely physical, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is intended for use with conditions that indicate the use of heat therapy, which is a therapeutic intervention.
No
The device is a heat therapy pack used for treatment, not for diagnosing conditions.
No
The device description clearly states it is a physical product containing sodium acetate, water, and a stainless steel disc in a nylon bag, which are hardware components.
Based on the provided information, the Recover® Instant Heat Therapy Pack is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "conditions that indicate the use of heat therapy." This describes a therapeutic application applied externally to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description of the components (sodium acetate, water, stainless steel disc) and how it works (provides heat) aligns with a physical therapy device, not a diagnostic one.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The Recover® Instant Heat Therapy Pack is a therapeutic device that applies heat externally.
N/A
Intended Use / Indications for Use
The Recover® Instant Heat Therapy Pack is intended for use with conditions that indicate the use of heat therapy.
Product codes
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Device Description
Food Grade Sodium Acetate and water with a stainless steel catalytic disc sealed in a nylon bag. Provides heat to 112ºF.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Prism Technologies Instant Warm Gel
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.5710 Hot or cold disposable pack.
(a)
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.(b)
Classification. 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.
0
DEC 12 1996
510(K) SUMMARY (as required by 807.92(c))
Submitter of 510(k):
Regulatory & Marketing Services, Inc. (RMS) 40178 U.S. 19 North Tarpon Springs, FL 34689
Phone: 813-942-3908 Fax: 813-942-3828
Contact Person:
Patrick J. Lamb
Date of Summary:
Trade Name:
Classification Name:
Predicate Device:
Device Description/ Comparison:
Patrick J. Lamb
September 13, 1996
Recover® Instant Heat Therapy Pack
Pack, Hot, Disposable
Prism Technologies Instant Warm Gel
Food Grade Sodium Acetate and water with a stainless steel catalytic disc sealed in a nylon bag. Provides heat to 112ºF.
| Proposed Device | Marketed Device | |
|---|---|---|
| Florida Medical | ||
| Industries | Prism Technologies | |
| Solution | Food-grade sodium acetate | |
| and water | Food-grade sodium | |
| acetate, gel and water | ||
| Disc | Stainless Steel Catalytic | |
| disk | Stainless Steel disc | |
| Temp. | 112° | 112° |
intended Use:
The Recover® Instant Heat Therapy Pack is intended for use with conditions that indicate the use of heat therapy.