Everyway EM-2400
by Everyway Medical Instruments Co., Ltd.
Everyway EM-2400 is a medical device (FDA Class II; FDA product code KPI, Stimulator, Electrical, Non-Implantable, For Incontinence) made by Everyway Medical Instruments Co., Ltd., cleared under FDA 510(k) K213116 on 3 Dec 2021 and listed in FDA GUDID since 17 Mar 2022 (UDI-DI 04719871183168), 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 | Number04719871183168 | Date17 Mar 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213116 | Date3 Dec 2021 | StatusActive |
Official records
- AccessGUDID record 04719871183168
- FDA 510(k) database K213116
Across registries
- FDA 510(k) K213116 decided 3 Dec 2021 Active
- FDA GUDID UDI-DI 04719871183168 listed 17 Mar 2022 Listed
Timeline
- Cleared FDA 510(k) K213116
- Listed FDA GUDID 04719871183168
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Everyway
- Generic name
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Model / reference
- EM-2400
- Primary DI / UDI-DI
- 04719871183168
- 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
Similar devices
Other devices filed under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence).
- NONIMPLANTED ELECTRICAL CONTINENCE DEVICE by Tridak Division of Indicon, Inc.
- Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) by Hunan Accurate Bio-Medical Technology Co.,Ltd.
- Pelvic Floor Stimulator (Intrelief PFE) by EasyMed Instruments Co., Ltd.
- PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) by Pontemedag
- Keffort (MC-100, MC-100A) by Oriental Inspiration Limited
- INNOVA PELVIC FLOOR STIMULATION SYSTEM by Empi
- MICROGYN PLUS STIMULATION DEVICE by Hollister, Inc.
- INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE by Empi
- Urinary Incontinence System by Guangzhou Finecure Medical Equipment Co., Ltd
- MyOnyx Mobile App SA9030 by Thought Technology Ltd.
Other devices from Everyway Medical Instruments Co., Ltd.
See all devices from Everyway Medical Instruments Co., Ltd. →