MSTIM-2000 EMS
510(k) K904332
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904332 | Date1 May 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
The MSTIM-2000 EMS is an electrical muscle stimulator (EMS), a device designed to deliver electrical impulses to stimulate muscle contractions. It is classified under the product code IPF and is intended for therapeutic applications in physical medicine. The device facilitates neuromuscular electrical stimulation (NMES) to aid in muscle re-education, pain management, and rehabilitation. Its design aligns with FDA-recognized standards for substantially equivalent physical medicine devices.
The MSTIM-2000 EMS is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K904332), granted on May 1, 1991. It is intended for use in clinical settings such as physical therapy or rehabilitation facilities, where trained professionals administer the device. No specific sterility requirements are noted in the regulatory data, but standard infection control practices should be followed. The device’s regulatory classification is Class II, and its use adheres to the guidelines established by the Physical Medicine Advisory Committee.