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Ems

by Saratoga Intl., Inc.

510(k) K931401

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 NumberK931401 Date23 Mar 1994ClearedStatusActive

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  • Withdrawn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, 20 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 EMS Transcutaneous Electrical Nerve Stimulator is a device classified under the Physical Medicine category, designed to deliver transcutaneous electrical nerve stimulation (TENS) for pain management. It operates by applying low-voltage electrical currents to the skin to modulate pain signals, typically used for acute or chronic pain relief in musculoskeletal or neurological conditions. The device is intended for non-invasive therapeutic applications, targeting peripheral nerve pathways to reduce discomfort without pharmacological intervention.

This device is supplied as a reusable medical instrument, requiring proper sterilization or disinfection between uses in clinical or home settings. It is not MRI-compatible and must be used in environments where magnetic resonance imaging is not performed. The EMS is authorized under FDA 510(k) clearance (K931401) and falls under the IPF product code, adhering to traditional review standards. Storage and handling follow standard electrical medical device protocols to ensure functionality and patient safety.

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