Identity
- Trade Name
- Intimd FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Electrical Muscel Stimulator (EMS) FDA UDI
- Model / Reference
- KWELL EM1 FDA UDI
- Description
- Electrical Muscel Stimulator (EMS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719871185575 FDA UDI
- 510(k) Number
- K213116 FDA UDI
- FDA Product Code
- KPI FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5320 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
Intimd by Everyway Medical Instruments Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Physical therapy transcutaneous neuromuscular electrical stimulation system.
- COMPEX — DJO, LLC · Class II
- RS-4s Muscle Stimulator System (R) — Rs Medical · Class II
- BodyMed — BOXOUT, LLC · Class II
- veicomtech — Guangzhou Huakai Electronic Technology Co., Ltd. · Class II
- Therapist’s Choice® TENS2N1 Combo — CLINICAL HEALTH SERVICES, INC. · Class II
- iSelfCare — HEALTHMATE INTERNATIONAL, LLC · Class II
- JMOON — Shenzhen Ulike Smart Electronics Co., Ltd. · Class II
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited · Class II
Cleared under the same submission
K213116 also covers:
- Everyway — EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- 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.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Everyway Medical Instruments Co., Ltd.
Sources (1)
- FDA UDI 5c0d9650-4a3f-4287-96fe-66fd90987719 34 fields · synced May 30, 2026