Vaginal 2 Electrode Stimulation/EMG Probe - Tampon

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K971541 ↗

FDA Product Code

KPI

Device Class

Class II

Regulation

21 CFR Part 876.5320

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Hollister, Inc. →

• What is the primary clinical purpose of this vaginal two-electrode stimulation/EMG probe, and how does it function?

  This device is designed for electromyographic (EMG) feedback and electrical stimulation of pelvic musculature, specifically for incontinence rehabilitation. It helps restore neuromuscular control and supports pelvic floor muscle rehabilitation by delivering targeted electrical stimulation during clinical use in urology and pelvic floor therapy.

• Is this probe intended for single-use or reusable applications, and what are the sterility considerations?

  The probe is supplied as a single-use, non-sterile device, meaning it is intended for one-time clinical use only. Since it is non-sterile, it should not be reused between patients, and standard medical device handling protocols for single-use probes should be followed to ensure patient safety.

• Are there any size or model variations for this vaginal stimulation/EMG probe, and how would I identify the correct one for a patient?

  The provided data does not specify distinct size or model variations for this probe. However, the registration numbers and FEI numbers listed (e.g., 3006636961, 1718873) may correspond to different lot or batch identifiers, but these are administrative, not clinical, distinctions. Clinicians should rely on manufacturer guidelines or product labeling for proper sizing and selection.

• What storage and handling instructions should be followed for this device, and does it have any special requirements?

  The probe follows standard medical device protocols for reusable or single-use probes, though it is explicitly non-sterile and single-use. Storage should be in a clean, dry environment, protected from contamination, and away from extreme temperatures or moisture. Since it is non-sterile, it should not be resterilized or reused, and proper disposal procedures should be followed after single-use.

• Does this device have any restrictions on use with MRI equipment, and what regulatory pathway was followed for its approval?

  The device has no specified MRI safety restrictions, meaning it is not contraindicated for use in MRI environments based on the available data. It was cleared through the FDA 510(k) pathway (K971541) under the classification of a non-implantable electrical stimulator for incontinence, with a substantially equivalent (SESE) determination by the Gastroenterology-Urology (GU) Advisory Committee.