Lifecare PR-02A
by Everyway Medical Instruments Co., Ltd.
Lifecare PR-02A is a Class II device made by Everyway Medical Instruments Co., Ltd., cleared under FDA 510(k) K213116 on 3 Dec 2021 (2 earlier submissions) and listed in FDA GUDID since 2 Dec 2016 (UDI-DI 04719871183410), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213116 | Date3 Dec 2021 | StatusActive |
| United States | GUDID listing | Number04719871183410 | Date2 Dec 2016 | StatusListed |
Official records
- AccessGUDID record 04719871183410
- FDA 510(k) database K213116
- FDA 510(k) database K161349
- FDA 510(k) database K122194
Across registries
- FDA 510(k) K213116 decided 3 Dec 2021 Active
- FDA GUDID UDI-DI 04719871183410 listed 2 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K122194
- Listed FDA GUDID 04719871183410
- Cleared FDA 510(k) K161349
- Cleared FDA 510(k) K213116
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Lifecare
- Generic name
- Perineal orifice incontinence-control electrical stimulation system probe, reusable
- Model / reference
- PR-02A
- Description
- Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
- Primary DI / UDI-DI
- 04719871183410
- FDA product code
- KPI, HIR
- GMDN term
- Perineal orifice incontinence-control electrical stimulation system probe, reusable
- Device class
- Class II
- Regulation number
- 876.5320, 884.1425
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
Similar devices
Other devices filed under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence).
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- INNOVA PELVIC FLOOR STIMULATION SYSTEM by Empi
- MICROGYN PLUS STIMULATION DEVICE by Hollister, Inc.
- Urinary Incontinence System by Guangzhou Finecure Medical Equipment Co., Ltd
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