Apollo Duet (Model : APD-4000)
FDA 510(k)Class II (US FDA 510(k))
by Weero Co.
Identifiers
- 510(k) Number
- K212253 FDA 510(k)
- FDA Product Code
- PBX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Apollo Duet (Model : APD-4000) is a professional pain management device that combines multipolar radio frequency (RF) and electroporation technologies. It is designed to provide relief from minor muscle aches, muscle spasms, and temporary improvement of local blood circulation. The device is intended for use in hospital or clinic settings.
The Apollo Duet is supplied as a single-use device and is not reusable. It is not MRI safe. The device is regulated under FDA 510(k) authorization and is intended for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation. The device is stored in a controlled environment to maintain its integrity.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Korea rf medical device manufacturer - weeroweero.com, Apollo Duet, Apollo Duet (Model : APD-4000) (K212253) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212253 | Class II | Active |
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Manufacturer
- Manufacturer
- Weero Co.
Sources (1)
- FDA 510(k) K212253 24 fields · synced Oct 1, 2026