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Sheer Energy Panty Hose

by Leggs Products, Inc.

510(k) K840335

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK840335 Date25 May 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a medical support stocking designed to prevent pooling of blood in the legs. It is classified as a Class II medical device under FDA regulation 880.5780.

The device received traditional 510(k) clearance (K840335) and is substantially equivalent to a predicate device. It is manufactured by Leggs Products, Inc. and is intended for general hospital use.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SHEER ENERGY PANTY HOSE intended for?

    The SHEER ENERGY PANTY HOSE is a medical support stocking designed to prevent pooling of blood in the legs, intended for general hospital use as a Class II device under FDA regulation 880.5780.

  • How was the SHEER ENERGY PANTY HOSE cleared for market?

    The device received traditional 510(k) clearance (K840335) and is substantially equivalent to a predicate device, meaning it was cleared based on demonstrating substantial equivalence to a legally marketed device.

  • Who manufactures the SHEER ENERGY PANTY HOSE and where is it made?

    The SHEER ENERGY PANTY HOSE is manufactured by Leggs Products, Inc., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States.