(90 days)
Not Found
Not Found
No
The summary describes a simple teether for infants and contains no mention of AI, ML, or related concepts.
No
The device is a teether, which helps relieve discomfort rather than treat a medical condition.
No
Explanation: The device is described as a teether for relieving teething discomfort, which is a therapeutic rather than a diagnostic function.
No
The device is described as a "fluid filled teether," which is a physical object and not software.
Based on the provided information, the Fu Hong Industries Limited Soother Teether is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to relieve teething discomfort in infants by providing a cooling effect. This is a physical interaction with the body, not a diagnostic test performed on samples taken from the body.
- Device Description: While the description is "Not Found," the intended use clearly indicates a physical device for soothing, not a diagnostic tool.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing diagnostic information
Therefore, the Fu Hong Industries Limited Soother Teether is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Fu Hong Industries Limited Soother Teether is a fluid filled teether indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.
Product codes
KKO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
teething infants
Intended User / Care Setting
Over-The-Counter Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.5550 Teething ring.
(a)
Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.(b)(1)
Classification. Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2005
FU Hong Industries Limited C/O Mr. Kevin Walls Regulatory Affairs Consultant Regulatory Insight, Incorporated 13 Red Fox Lane Littleton, Colorado 80127
Re: K052531
Trade/Device Name: Fu Hong Industries Limited Soother Teether Regulation Number: 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: November 28, 2005 Received: November 29, 2005
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual 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 has of be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
1
Page 2 - Mr. Walls
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be advised that 122 to to mination that your device complies with other requirements mount that i Drimas made statutes and regulations administered by other Federal agencies. or the Act of any I ederal the Act's requirements, including, but not limited to: registration r od intest comply with as a 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 CF read in the quality systems (QS) regulation (21 CFR Part 820); and if requirenches as bet form in adiation 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) rins leter notification. The FDA finding of substantial equivalence of your device to a premaired predicate device results in 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), rr you desire speeme at (240) 276-0115. Also, please note the regulation 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 obtain 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/industry/support/index.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): 42522531
2004年 2008年 11:40 000 2 2 5 00 4 24 2007 2007 000 2007 000 200 2007 000 1 0 200 10 200 000 000
AKO: K : EXIDA | YANIM : 1 4K : PK : RK : RK : REA TEN : KE
Device Name: Fu Hong Industries Limited Soother Teether
Indications for Use: The Fu Hong Industries Limited Soother Teether is a fluid filled teether indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
15 годишна стати композиции и везманиции комуници и представились мерельность коему продожения коев г. на сельма
Susan Russo
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