Identity
- Trade Name
- Foot Switch joimax® Endovapor®2 EUDAMEDEndovapor® FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Foot Switch joimax® Endovapor®2 EUDAMEDFDA UDI
- Model / Reference
- REFUSS01 EUDAMEDFDA UDI
- Description
- Foot Switch joimax® Endovapor®2 FDA UDI
Identifiers
- Catalog Number
- REFUSS01 FDA UDI
- Primary DI / UDI-DI
- 04250337108405 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371FUSSENDMZ EUDAMED
- Direct Marketing DI
- 04250337108405 EUDAMED
- 510(k) Number
- K170358 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Category: Foot-switch, electrical
Endovapor® by Joimax, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K170358 also covers:
- Endovapor® — JOIMAX, INC.
- Endovapor® — JOIMAX, INC.
- Endovapor® — JOIMAX, INC.
- Endovapor® — JOIMAX, INC.
- Endovapor® — JOIMAX, INC.
- Endovapor® — JOIMAX, INC.
- Endovapor®2 — JOIMAX, INC.
- Surgi-Max™ — JOIMAX, INC.
- Surgi-Max™ — JOIMAX, INC.
- Surgi-Max™ — JOIMAX, INC.
- Surgi-Max™ — JOIMAX, INC.
- Surgi-Max™ — JOIMAX, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI 88d1a55a-9ff0-4919-a6a5-9a0ac1707208 37 fields · synced Jul 29, 2026
- EUDAMED 934b544e-b70a-4b3e-9e77-4f387b36d756 61 fields · synced Jun 14, 2026