Identifiers
- 510(k) Number
- K960342 FDA 510(k)
- FDA Product Code
- LKY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5020 FDA 510(k)
- Regulation Number
- 876.5020 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The POS-T-VAC AVP-1000 & MVP-700 is an external penile rigidity device intended to create or maintain sufficient penile rigidity for sexual intercourse. It is classified as a Class II medical device under FDA regulation number 876.5020.
The device is supplied as a single-use item and is not reusable. It is not specified whether it is sterile or requires specific storage conditions. The device is authorized under FDA 510(k) clearance, with a decision of Substantially Equivalent.
Frequently asked questions
What is the POS-T-VAC AVP-1000 & MVP-700 used for?
This device is an external penile rigidity device intended to create or maintain sufficient penile rigidity for sexual intercourse.
Is the POS-T-VAC AVP-1000 & MVP-700 reusable?
No, the device is supplied as a single-use item and is not reusable.
What is the regulatory status of the POS-T-VAC AVP-1000 & MVP-700?
The device is authorized under FDA 510(k) clearance with a decision of Substantially Equivalent.
What is the classification of the POS-T-VAC AVP-1000 & MVP-700?
It is classified as a Class II medical device under FDA regulation number 876.5020.
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: POS-T-VAC AVP-1000 & MVP-700 (K960342) — FDA 510(k) | Innolitics, POS-T-VAC AVP-1000 & MVP-700 by POS-T-VAC, INC. | FDA 510 (k) Summary, POS-T-VAC AVP-1000 & MVP-700 510(k) K960342 - FDA.report, PDF K960342 - Pos-t-vac Avp-1000 & Mvp-700
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K960342 | Class II | Active |
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Manufacturer
- Manufacturer
- Pos-T-Vac Inc
- FDA Applicant
- Pos-T-Vac, Inc.
Sources (1)
- FDA 510(k) K960342 24 fields · synced Sep 27, 2026