Identity
- Trade Name
- swiftPro DC power adaptor FDA UDI
- Generic Name
- Electrical mains power cable FDA UDI
- Device Name
- The swiftPro DC power adaptor is used to power the swiftPro hand-held generator FDA UDI
- Model / Reference
- SWF-DCA01 FDA UDI
- Description
- The swiftPro DC power adaptor is used to power the swiftPro hand-held generator FDA UDI
Identifiers
- Catalog Number
- SWF-DCA01 FDA UDI
- Primary DI / UDI-DI
- 05060652910077 FDA UDI
- 510(k) Number
- K222388 FDA UDI
- FDA Product Code
- NEY FDA UDI
- GMDN Term
- Electrical mains power cable 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: Electrical mains power cable
swiftPro DC power adaptor by Emblation Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Vapotherm — Vapotherm Inc.
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Cleared under the same submission
K222388 also covers:
- swiftPro Cradle — 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 56b6427c-f87f-4756-9eab-bd6734293485 35 fields · synced Jun 6, 2026