Identifiers
- 510(k) Number
- K073716 FDA 510(k)
- FDA Product Code
- MKJ FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5310 FDA 510(k)
- Regulation Number
- 870.5310 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LifeCel Battery Pack, Model 51500, is a rechargeable battery designed for use with automated external defibrillator (AED) systems. It provides the necessary power supply to deliver life-saving electrical shocks during cardiac emergencies, ensuring continuous operation of the defibrillator when connected. This component is integral to maintaining functionality in non-wearable AED systems, where reliability and rapid response are critical.
Supplied as a reusable component, the LifeCel Battery Pack is intended for use in Class III medical devices regulated under 21 CFR 870.5310 for automated external defibrillator systems. It is not sterile and must be handled in accordance with manufacturer guidelines to ensure proper charging, storage, and replacement cycles. The device holds FDA 510(k) clearance (K073716) and is distributed by Amco International Manufacturing & Design, Inc. from Elizabeth, Colorado.
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: LIFE+CEL OR LIFECEL BATTERY (K073716) — FDA 510(k) | Innolitics, Life+Cel or Lifecel Battery Pack, Model 5l500, Life+Cel or Lifecel Battery Pack, Model 5l500, Amco & Design Life+cel OR Lifecel Battery - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K073716 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amco International Manufacturing & Design, Inc.
Sources (1)
- FDA 510(k) K073716 24 fields · synced Sep 20, 2026