Jobst-Custom
510(k) K925154
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK925154 | Date4 Apr 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DWL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5780
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The JOBST-CUSTOM is a medical support stocking designed to prevent pooling of blood in the legs. It is a Class II medical device that provides compression therapy for venous disorders.
The device is supplied as a custom-fitting stocking and is intended for single-use. It is not MRI compatible and should be stored according to manufacturer instructions. The JOBST-CUSTOM has received FDA 510(k) clearance with product code DWL.
Other devices from Jobst Institute, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the JOBST-CUSTOM medical support stocking used for?
The JOBST-CUSTOM is a medical support stocking designed to prevent pooling of blood in the legs. It provides compression therapy for venous disorders as a Class II medical device.
How is the JOBST-CUSTOM supplied and is it reusable?
The JOBST-CUSTOM is supplied as a custom-fitting stocking and is intended for single-use only. It should not be reused as per the manufacturer's instructions.
What are the storage requirements for the JOBST-CUSTOM?
The JOBST-CUSTOM should be stored according to the manufacturer's instructions. It is not MRI compatible, so proper storage conditions should maintain its effectiveness while avoiding exposure to MRI environments.
What regulatory clearance has the JOBST-CUSTOM received?
The JOBST-CUSTOM has received FDA 510(k) clearance with product code DWL. It was determined to be substantially equivalent to other medical support stockings for preventing blood pooling in the legs.