(39 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other indicators of AI/ML technology. The device description is a simple warming blanket.
No
The device is described as providing "warm relief," which is a comfort measure, not a therapeutic treatment for a medical condition.
No
Explanation: The intended use of the device is "to provide warm relief," which describes a therapeutic or comfort function, not a diagnostic one. Diagnostic devices are used to identify or determine the nature of a disease or condition.
No
The device description explicitly states "Ready Heat™ blanket," which is a physical hardware product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To provide warm relief." This describes a therapeutic or comfort function, not a diagnostic one.
- Device Description: The device is a "Ready Heat™ blanket." This is a physical item used externally, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, based on the provided details, the Ready Heat™ blanket is a device for providing warmth and is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To provide warm relief
Product codes
KME
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6060 Medical disposable bedding.
(a)
Identification. Medical disposable bedding is a device intended for medical purposes to be used by one patient for a period of time and then discarded. This generic type of device may include disposable bedsheets, bedpads, pillows and pillowcases, blankets, emergency rescue blankets, or waterproof sheets.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
Public Health Service
SEP 17 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TECHTRADE LLC C/O Dr. Arthur M. Horowitz Arthur M. Horowitz & Associates, Incorporated 11900 Gainsborough Road Potomac, Maryland 20854-3305
Re: K042145
Trade/Device Name: Ready Heat™ Blanket Regulation Number: 880.6060 Regulation Name: Medical Disposable Bedding Regulatory Class: I Product Code: KME Dated: September 1, 2004 Received: September 2, 2004
Dear Dr. Horowitz:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nate reviewed young young the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device intersule commerce proves that have been reclassified in accordance with the provisions of Amendinons, or to act read Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions was registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Nr.), It may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be foundish further announcements concerning your device in the Federal Register.
1
Page 2 -Dr. Horowitz
Please be advised that FDA's issuance of a substantial equivalence determination does not I Toast be authout that 12 a determination that your device complies with other requirements mean that I Dr may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal state s requirements, including, but not limited to: registration 1 ou must comply with and 07); labeling (21 CFR Part 801); good manufacturing practice and ilsuing (21 OF R Part 807), systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter while are n your end finding of substantial equivalence of your device to a premaired predicated. - I a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number: (if known): K042145
Device Name: Ready Heat™ blanket
Indications for Use: To provide warm relief
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR .
Over the Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUNE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rander R. Sluy for ADW 9/16/04
(Division Sign-Off) Division of Anesthesiology, General Ho Infection Control. Denta
510(k) Number: K042145