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510(k) Data Aggregation
K Number
K160667Device Name
Anybattery C2 Rechargeable Battery
Manufacturer
Date Cleared
2017-05-11
(428 days)
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
Anybattery, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To power the functions of various devices for which batteries or battery packs are configured.
Since rechargeable batteries and battery packs are "device specific" and are designed to operate and fit into the equipment for which they were manufactured only qualified personnel should evaluate, test, charge, or install these devices.
Battery Packs are is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
Device Description
Batteries have become a critical component in many medical devices. As more devices are computerized and more have become mobile, batteries play an important part in system performance and reliability. Medical batteries are treated as a piece of medical equipment, they are entered as an asset into the facilities equipment database and our included in the preventative maintenance schedule. The end use of the equipment is used to establish the frequency for preventative maintenance. Both the recommendation of the manufacturer of the medical device and the battery spec sheet from the battery manufacturer help establish the maintenance protocol.
Anybattery C2 Rechargeable batteries and battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical equipment.
Anybattery C2 Rechargeable batteries and battery packs either the primary or secondary source of power and they retain critical parameters and data in the event of power disruption. These batteries range in size, while they are mostly 12-volt, they range in capacity from two-amp hour right up to 36-amp hour batteries.
The performance and life span of a rechargeable battery depends on several factors. Battery operating conditions of temperature, current drain, and charge/discharge method. are taken into account in the design of such batteries. Anybattery's goal is to develop a battery that maintains its battery capacity as high as possible and as long as possible.
There are several types of rechargeable batteries introduced and marketed for medical uses. In this submission are batteries in the Nickel-Based Rechargeable Battery Product Family and the Valve-Regulated Lead-Acid (VRLA) Rechargeable Battery Product Family.
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