EMS Adapter Model 9160

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K791541 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What clinical settings is the EMS Adapter Model 9160 intended for use in, and how does it support electromyography procedures?

  The EMS Adapter Model 9160 is designed for use in clinical environments like hospitals, outpatient clinics, and research facilities. It serves as an adapter in electromyographic (EM) systems to connect electrodes to recording equipment, ensuring accurate signal transmission for assessing muscle and nerve function during electromyography procedures.

• Is the EMS Adapter Model 9160 single-use or reusable, and what maintenance is required between uses?

  The EMS Adapter Model 9160 is a reusable component and must be cleaned and maintained according to the manufacturer’s guidelines between uses. Since it is not sterile, proper disinfection is essential to ensure safe and reliable performance across multiple procedures.

• What regulatory pathway was followed for FDA clearance of the EMS Adapter Model 9160, and what advisory committee was involved?

  The EMS Adapter Model 9160 received FDA clearance through a traditional 510(k) process (K791541) and was classified under the product code GEI. The device was reviewed by the General, Plastic Surgery advisory committee (SU) and determined to be substantially equivalent to a predicate device.

• Are there any specific safety considerations for using the EMS Adapter Model 9160, particularly regarding MRI compatibility or electrical safety?

  The EMS Adapter Model 9160 does not provide specific MRI safety information, so its use near MRI equipment should follow standard safety protocols. Additionally, it must comply with general electrical safety guidelines to ensure safe operation during electromyography procedures.