iSTIM PR-13A
by Everyway Medical Instruments Co., Ltd.
iSTIM PR-13A is a Class II device made by Everyway Medical Instruments Co., Ltd., cleared under FDA 510(k) K213116 on 3 Dec 2021 and listed in FDA GUDID since 30 Aug 2023 (UDI-DI 04719871189108), 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 | GUDID listing | Number04719871189108 | Date30 Aug 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213116 | Date3 Dec 2021 | StatusActive |
Official records
- AccessGUDID record 04719871189108
- FDA 510(k) database K213116
Across registries
- FDA 510(k) K213116 decided 3 Dec 2021 Active
- FDA GUDID UDI-DI 04719871189108 listed 30 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K213116
- Listed FDA GUDID 04719871189108
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iSTIM
- Generic name
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Model / reference
- iSTIM PR-13A
- Description
- Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
- Primary DI / UDI-DI
- 04719871189108
- 510(k) Number
- FDA product code
- KPI
- GMDN term
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Device class
- Class II
- Regulation number
- 876.5320
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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