(173 days)
Not Found
No
The device description and intended use describe a standard electric heating pad with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for the relief of minor muscular or joint pain, which is a therapeutic purpose.
No
The device is an electric heating pad used for comfort and pain relief, which is a therapeutic function. It does not perform any diagnostic function such as identifying, detecting, or monitoring a disease or condition.
No
The device description clearly states it is an "Electric Heating Pad" with physical dimensions and operates on standard household current, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for applying heat to the body for personal comfort and relief of minor muscular or joint pain. This is a physical therapy or comfort application, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an electric heating pad. This is a physical device that applies heat externally. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a therapeutic or comfort device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Use wherever hot applications are desirable for personal comfort, and wherever recommended by your physician, dentist or health care professional for the relief of minor muscular or joint pain.
Product codes
Not Found
Device Description
Electric Heating Pad, 11.5" x 14.5" conforming to ANSI / UL Standard #130, Electric Heating Pads, operating on standard 110-120V household current. The units are supplied with removable covers and sponge inserts for moist heat applications, with instructions, in conventional 4-color printed boxes, and are marketed through consumer retail channels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.5740 Powered heating pad.
(a)
Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.
0
Image /page/0/Picture/0 description: The image shows the logo for Health o meter. The logo consists of a stylized symbol on the left and the text "Health o meter" on the right. The symbol appears to be a stylized representation of a scale or balance, with three horizontal lines above two downward-pointing triangles.
510(k) Summary K962195
NOV 2 7 1996
| Submission Date: | September 5, 1996 |
|---|---|
| Contact: | Frank Brichetto |
| Sr. Product Manager | |
| (708) 298-9100 x 401 - tel. | |
| (708) 233-5472 - fax | |
| Classification Name: | Powered Heating Pad (21 CFR, 890.5740) |
| Common/Usual Name: | Electric Heating Pads |
| Proprietary Name: | Health o meter Electric Heating Pads, |
| Models EHP2, EHP3 | |
| Classification: | Class II |
| Description: | Electric Heating Pad, 11.5" x 14.5" conforming to ANSI / UL |
| Standard #130, Electric Heating Pads, operating on standard 110-120V household current |
rent. The units are supplied with removable covers and sponge inserts for moist heat applications, with instructions, in conventional 4-color printed boxes, and are marketed through consumer retail channels.
- Intended Use: Use wherever hot applications are desirable for personal comfort, and wherever recommended by your physician, dentist or health care professional for the relief of minor muscular or joint pain.
- Substantial Equivalence Claim: The Models EHP2 are substantially equivalent to the following models which are currently in distribution:
| 1. | Conair Moist Heat Pad, | K924799 |
|---|---|---|
| 2. | Conair Moist Heat Pad with Automatic Shut-off, | K924800 |
| 3. | Sunbeam / Walgreens Heating Pad | none |
Substantial equivalence is claimed because: the power source, manufacturing technology, operating principles, intended uses and safety standards are the same for all models. Differences are primarily cosmetic.
Revised September 4, 1996.