Identity
- Trade Name
- swiftPro Cradle FDA UDI
- Generic Name
- Microwave hyperthermia system FDA UDI
- Device Name
- The swiftPro Cradle is the stand for the swiftPro Hand-Held Microwave Generator when not in use. FDA UDI
- Model / Reference
- SWF-CRA01 FDA UDI
- Description
- The swiftPro Cradle is the stand for the swiftPro Hand-Held Microwave Generator when not in use. FDA UDI
Identifiers
- Catalog Number
- SWF-CRA01 FDA UDI
- Primary DI / UDI-DI
- 05060652910084 FDA UDI
- 510(k) Number
- K222388 FDA UDI
- FDA Product Code
- NEY FDA UDI
- GMDN Term
- Microwave hyperthermia system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
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: Microwave hyperthermia system
swiftPro Cradle by Emblation Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microwave hyperthermia system.
- HS AMICA — H.S. HOSPITAL SERVICE SPA · Class II
- BSD-500 Hyperthermia System — Pyrexar Medical, Inc. · Class III
- HS AMICA — H.S. HOSPITAL SERVICE SPA · Class II
- BSD-2000 Hyperthermia System — Pyrexar Medical, Inc. · Unclassified
- Emprint HP — Covidien LP · Class II
- Emprint — Covidien LP · Class II
- BSD-2000 Hyperthermia System — Pyrexar Medical, Inc. · Unclassified
- Solero — ANGIODYNAMICS, INC · Class II
Cleared under the same submission
K222388 also covers:
- swiftPro DC power adaptor — Emblation Limited
- swiftPro Hand-Held Microwave Generator — Emblation Limited
- swiftPro LRT Applicator Tip — Emblation Limited
- swiftPro LRT Applicator Tip — Emblation Limited
- swiftPro System — Emblation Limited
- swiftPro URT Applicator Tip — Emblation Limited
- swiftPro URT Applicator Tip — Emblation Limited
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
- Emblation Limited
Sources (1)
- FDA UDI ee239072-9741-44eb-92b1-a04d7d73f5a1 35 fields · synced Jun 6, 2026