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Electronic Muscle Exercise Equipment (K841779)

by Bloomex International, Inc. 510(k)

Active United States

510(k) K841779

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK841779 Date30 May 1984ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Electronic Muscle Exercise Equipment
510(k) Number
FDA Product Code
IPF
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 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 classified as Electronic Muscle Exercise Equipment, designed to stimulate muscle contraction through electrical impulses. It falls under the Physical Medicine category and is intended for therapeutic use in muscle rehabilitation, strengthening, or maintenance. The device delivers controlled electrical stimulation to promote muscle activity, aiding in recovery or fitness regimens.

The equipment is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K841779) with a Traditional clearance type. It is intended for use in clinical or home settings, adhering to Product Code IPF for physical medicine devices. No specific sterility or MRI safety details are provided in the data, and no additional regulatory approvals beyond the 510(k) are mentioned.

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