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IF2000 Electrical Muscle Stimulator Unit

by Rich-Mar Corp.

510(k) K893994

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 NumberK893994 Date14 Dec 1989ClearedStatusActive

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  • Withdrawn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
IPF
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The IF2000 Electrical Muscle Stimulator Unit is a powered muscle stimulator that delivers electrical impulses to skeletal muscle tissue for therapeutic stimulation. It is designed for use in physical medicine to elicit muscle contractions and support rehabilitation protocols.

The unit is supplied as a single, reusable device and was cleared by the FDA through a traditional 510(k) submission (K893994) as a Class II medical device with product code IPF. It is classified as a Stimulator, Muscle, Powered and is subject to the applicable special controls for this category.

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Questions

AI-generated answers, 23 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 therapeutic purpose does the IF2000 Electrical Muscle Stimulator serve?

    It provides electrical impulses to skeletal muscle tissue to elicit controlled contractions, which helps patients regain strength, improve circulation, and support rehabilitation protocols in physical medicine settings.

  • Is the IF2000 supplied as a single unit or multiple components?

    The device is supplied as a single, reusable unit. All necessary hardware for delivering stimulation is integrated, so clinicians receive one complete system ready for use after proper cleaning and maintenance.

  • Can the IF2000 be used for multiple patients, and what sterility considerations apply?

    Yes, the IF2000 is designed for repeated use across patients. Because it is not a sterile, disposable product, it must be cleaned and disinfected according to the manufacturer’s instructions between patients to prevent cross‑contamination.

  • What regulatory pathway was used for the IF2000’s market clearance?

    The IF2000 received FDA clearance through a traditional 510(k) submission (K893994), demonstrating substantial equivalence to a legally marketed predicate device and meeting the special controls for Class II muscle stimulators.