Chrysalis Intelligence · Product Codes · QAJ

QAJ · Cutaneous Electrode Stimulator For Urinary Incontinence

Gastroenterology, Urology · 3 clearances · 2 unique sponsors

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Device class

Class II

Regulation 876.5330

Total clearances

2020-01-16 → 2026-01-23

Last 12 months

Unique sponsors

Definition

What is Cutaneous Electrode Stimulator For Urinary Incontinence

A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.

Classification details

Medical specialty

Gastroenterology, Urology

Review panel

Regulation number

876.5330

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Elidah, Inc.	2	1	2026-01-23
Atlantic Therapeutics, Ltd.	1	0	2020-01-16

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.

Code	Type	Description	Confidence	Rationale
64553	CPT	—	High	CPT for percutaneous stimulation of sacral nerve for urinary incontinence
97014	CPT	—	Medium	CPT for electrical stimulation for therapeutic purposes (transcutaneous)

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-01-23	K253285	Elidah, Inc.	Elitone for Men
2023-02-24	K223884	Elidah, Inc.	ELITONE Urge Urinary Incontinence Device
2020-01-16	K192357	Atlantic Therapeutics, Ltd.	INNOVO