Palmer Obstetric Brace
by Ad-Tech Medical Instrument Corp.
510(k) K864194
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864194 | Date14 Jan 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KNC
- FDA applicant
- Ad-Tech Medical Instrument Corp
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4900
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Palmer Obstetric Brace is a medical device classified as a Table, Obstetric (and Accessories), designed to support and stabilize a patient during obstetric procedures. It is intended for use in obstetrics to provide a stable platform for the patient’s lower body, facilitating optimal positioning for delivery or related interventions. The device is engineered to reduce physical strain on both the patient and healthcare provider during labor and delivery.
This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K864194), with a decision date of January 14, 1987. It falls under Class II – Special Controls for obstetrics/gynecology applications and is intended for use in clinical settings where obstetric support is required. No information regarding MRI safety or sterility is provided in the available data.
Other devices from Ad-Tech Medical Instrument Corp.
Questions
AI-generated answers, 20 Sep 2026
What is the primary purpose of the Palmer Obstetric Brace in a clinical setting?
The Palmer Obstetric Brace is designed to support and stabilize a patient’s lower body during obstetric procedures, such as labor and delivery. It provides a stable platform to help position the patient optimally, reducing physical strain on both the patient and healthcare provider while facilitating smoother interventions.
Is the Palmer Obstetric Brace intended for single-use or reusable applications?
The Palmer Obstetric Brace is explicitly supplied as a reusable medical instrument. There is no mention of single-use packaging or sterilization requirements in the available data, so it is meant for repeated use in clinical settings.
How is the regulatory status of this device determined, and what classification does it fall under?
The Palmer Obstetric Brace is regulated under the FDA 510(k) clearance process, specifically with a Traditional 510(k) submission (K864194). It is classified as Class II under the FDA’s special controls for obstetrics/gynecology applications, with a decision date of January 14, 1987, confirming it is substantially equivalent to a predicate device.
What types of obstetric procedures is this brace intended to assist with?
While the device is classified as a Table, Obstetric (and Accessories), its intended use is to provide a stable platform for the patient’s lower body during labor and delivery, as well as related obstetric interventions. It is not specified for surgical procedures beyond childbirth support.
Does the manufacturer provide any information about compatibility with MRI equipment?
The available data does not include any details regarding the MRI safety of the Palmer Obstetric Brace. Clinicians should verify compatibility with their facility’s MRI protocols before use if needed.