Adel Medical Birthing Bed #LD-500
510(k) K810886
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810886 | Date23 Apr 1981 | 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- Withdrawn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
- HDD
- FDA applicant
- Adel Medical , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4900
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Adel Medical Birthing Bed #LD-500 is an obstetrical, AC-powered table designed for use in labor and delivery settings. Classified as a Table, Obstetrical, AC-Powered (and Accessories), it is engineered to provide specialized support during childbirth procedures. This device is intended for clinical environments where obstetric care is administered, ensuring patient comfort and operational efficiency during labor.
The #LD-500 is supplied as a reusable medical device and is intended for use in hospital birthing suites. It has received FDA 510(k) clearance under K810886, classified as a Class II device under regulation number 884.4900. The device is not specified as MRI-safe or single-use, and no sterility requirements are indicated in the available data. Maintenance and servicing may include diagnostic evaluation, troubleshooting, and component-level repairs as needed for operational integrity.
Other devices from Adel Medical, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Adel Medical Birthing Bed #LD-500 used for?
The Adel Medical Birthing Bed #LD-500 is an obstetrical, AC-powered table specifically designed for labor and delivery settings. It provides specialized support during childbirth procedures, enhancing patient comfort and operational efficiency in hospital birthing suites.
Is the Adel Medical Birthing Bed #LD-500 reusable or single-use?
The Adel Medical Birthing Bed #LD-500 is supplied as a reusable medical device. It is intended for repeated use in hospital birthing suites, with maintenance and servicing including diagnostic evaluation, troubleshooting, and component-level repairs as needed.
What regulatory clearance does the Adel Medical Birthing Bed #LD-500 hold?
The device has received FDA 510(k) clearance under the reference number K810886. It is classified as a Class II device under regulation number 884.4900, with a decision of substantial equivalence in obstetrics/gynecology.
Does the Adel Medical Birthing Bed #LD-500 require sterilization?
The available data does not specify any sterility requirements for the Adel Medical Birthing Bed #LD-500. However, as a reusable device, it should be cleaned and maintained according to standard hospital protocols to ensure patient safety and operational integrity.
What maintenance is recommended for the Adel Medical Birthing Bed #LD-500?
Maintenance for the Adel Medical Birthing Bed #LD-500 may include diagnostic evaluation, troubleshooting, and component-level repairs to ensure its operational integrity. Regular servicing is advised to address any mechanical or functional issues and maintain performance standards.