Identity
- Trade Name
- Everyway FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Electrical Muscel Stimulator (EMS) FDA UDI
- Model / Reference
- EV-805I FDA UDI
- Description
- Electrical Muscel Stimulator (EMS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719871189238 FDA UDI
- 510(k) Number
- K161349 FDA UDI
- FDA Product Code
- NGX FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Everyway by Everyway Medical Instruments Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K161349 also covers:
- Everyway — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- Everyway — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- Lifecare — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- Lifecare — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- Lifecare — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- iSTIM — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- iSTIM — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- iSTIM — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- iSTIM — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- iSTIM — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Everyway Medical Instruments Co., Ltd.
Sources (1)
- FDA UDI 4de2ac30-f6d0-402b-a4a6-3afeae56dcf6 34 fields · synced May 30, 2026