ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS

• K Number: K123561
• Device Name: ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS
• Manufacturer: BSN MEDICAL, INC.
• Date Cleared: 2012-12-18 ( 29 days)
• Product Code: DWL
• Regulation Number: 880.5780
• Type: Special
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

For the management of lymphedema and other edema.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA for medical support stockings (Elvarex / Elvarex Soft / Elvarex Soft Seamless). This document does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for AI/algorithm-based devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given text. This document is a regulatory clearance letter, not a clinical study report or a technical performance evaluation.

Regulation Number and Section

§ 880.5780 Medical support stocking.

(a)
Medical support stocking to prevent the pooling of blood in the legs —(1)Identification. A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg.(2)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.(b)
Medical support stocking for general medical purposes —(1)Identification. A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.