Model EM-IR
510(k) K810528
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810528 | Date31 Mar 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KZM
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.1375
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The device is a muscle monitoring device, as defined by its device type and nomenclature. It is identified as MODEL EM-IR with product code KZM and was cleared via the FDA 510(k) process under K810528.
It was submitted by Myo-Tronics Research, Inc. and received on February 26, 1981, with a decision date of March 31, 1981. The device is classified as Class II and falls under regulation number 890.1375 for physical medicine applications.
Other devices from Myo-Tronics Research, Inc.
Questions
AI-generated answers, 28 Sep 2026
What is the MODEL EM-IR device used for?
The MODEL EM-IR is a muscle monitoring device intended for physical medicine applications, as defined by its device type and nomenclature, and was cleared as substantially equivalent to a predicate device.
How was the MODEL EM-IR device cleared for market?
The MODEL EM-IR received clearance through the FDA 510(k) process under submission K810528, with a decision date of March 31, 1981, based on a determination of substantial equivalence.
Who manufactures the MODEL EM-IR device and where are they located?
The MODEL EM-IR is manufactured by Myo-Tronics Research, Inc., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States.