Chrysalis Intelligence · Product Codes · QRC

QRC · Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

Gastroenterology, Urology · 4 clearances · 2 unique sponsors

Device class
Class II
Regulation 876.5026
Total clearances
4
2021-11-23 → 2026-04-06
Last 12 months
1
Unique sponsors
2
Definition

What is Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.5026
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Virility Medical , Ltd. 3 1 2026-04-06
Morari, Inc. 1 0 2025-02-11
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
53899 CPT Low Unlisted procedure, genitalia; electrical stimulation for ejaculation disorder
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-06 K252809 Virility Medical , Ltd. in2 Smart (in2S)
2025-02-11 K241897 Morari, Inc. MOR
2023-05-01 K223595 Virility Medical , Ltd. vPATCH
2021-11-23 DEN210012 Virility Medical vPatch