(286 days)
Not Found
No
The device description and performance studies focus on material safety and mechanical properties, not computational capabilities. There is no mention of AI, ML, or data processing.
No.
The primary purpose of a therapeutic device is to treat or alleviate a medical condition. While this teether aims to "ease babies teething pain," which sounds therapeutic, its classification as a "Class II Fluid-Filled Teething Ring" and the numerous toy safety standards it meets (ASTM F963, 16 CFR 1500, EN 71, etc.) indicate it is regulated as a general consumer product for comfort rather than a medical device providing specific therapy. The predicate device also refers to a "WATER FILLED TEETHER," not a therapeutic device.
No
The device is described as a "teether" designed to ease "babies teething pain" and is classified as a "Class II Fluid-Filled Teething Ring." Its purpose is to provide comfort, not to diagnose any condition.
No
The device description clearly states it is a "Class II Fluid-Filled Teething Ring (Teether with waterfilled part)" and lists numerous physical and material standards it meets, indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- MAM Twister Teether Function: The provided information clearly states the MAM Twister Teether is a physical device designed to be chewed on by babies to soothe teething pain. It is a Class II Fluid-Filled Teething Ring.
- Lack of Diagnostic Purpose: There is no mention of this device being used to analyze biological samples or provide any diagnostic information about a baby's health. Its purpose is purely physical comfort and pain relief.
- Relevant Standards: The standards listed (USP , ASTM F963, 16 CFR, CPSIA, EN 71) are related to the safety and physical properties of toys and consumer products, not diagnostic testing.
Therefore, based on the provided information, the MAM Twister Teether is a consumer product designed for physical comfort during teething, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MAM Twister Teether was developed for the needs of babies who are having their first teeths. It is designed to offer optimum comfort and safety for the baby and offers all the soothing textures and cooling comfort in order to ease babies teething pain.
Product codes
KKO
Device Description
Class II Fluid-Filled Teething Ring (Teether with waterfilled part) that that meets requirements of USP , ASTM F963 section 4.3.6.1 & 4.3.6.3, 16 CFR 1303 - Ban of lead-containing paint (, ASTM F963 section 4.3.6.1 & CFR 1303 - Ban of lead-containing paint (
§ 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/0 description: The image shows the word "MAM" in large, bold, white letters against a textured, gray background. The background appears to be composed of small, repeating patterns or characters, creating a visually noisy effect. The overall design is simple yet striking, with the contrast between the white text and the gray background making the word "MAM" stand out prominently.
JUN 2 3 2010
Section C 510(k) Summary (21 CFR 807.92)
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is: K092781
(a) (1) The summary contains on the first page, preferably on your letterhead paper, the submitters name, address, phone and fax numbers, name of contact person, and date the summary was prepared:
Submitter's name: Submitter' s address:
Contact Name:
Phone No .: Fax No.:
Facility Registration No .: Owner Operator No .:
MAM International AG Wilenstraße 17 8832 Wollerau, Schwyz Switzerland
Markus Schoell
0043-1-49141-715 0043-1-49141-719
3003296982 9054867
Date of Summary:
23.07.2009
(a) (2) The name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name if known:
| Device Name/ Trade Name:: | MAM Twister |
|---|---|
| Classification Name: | Fluid-Filled Teething Ring |
| Device Classification: | II |
| Regulation Number: | 872.5550 |
| Panel: | Dental |
| Product Code : | KKO |
1
Image /page/1/Picture/0 description: The image is a square icon with rounded corners. The background of the icon is white. In the center of the icon, there is the text "MAM" in bold, black letters. The letters are outlined in black, giving them a slightly raised appearance.
(a) (3) An identification of the legally marked device to which your firm is claiming substantial equivalence:
Class II Fluid-Filled Teething Ring (Teether with waterfilled part) that that meets requirements of USP . ASTM F963 section 4.3.6.1 & 4.3.6.3. 16 CFR 1303 - Ban of lead-containing paint (, ASTM F963 section 4.3.6.1 & 4.3.6.3, 16 CFR 1303 - Ban of lead-containing paint ( / ASTM F963 section 4.3.6.1 | Meets |
| Cleanliness of products used in toys | ASTM F963 section 4.3.6.3 | Meets |
| Ban of lead-containing paint | 16 CFR 1303 | Meets (, ASTM F963 section 4.3.6.1 & CFR 1303 - Ban of lead-containing paint (