Life Warmer Quantum Charger - The Quantum Charger from LifeWarmer is an - LIFE WARMER INC

Duns Number:032045686

Device Description: The Quantum Charger from LifeWarmer is an AC-powered reusable device that can fully charge The Quantum Charger from LifeWarmer is an AC-powered reusable device that can fully charge the Quantum Battery rapidly and safely. The Charger has built-in algorithms to ensure proper, steady charging without overcharging or damaging the health and integrity of the battery. The Battery can go from nearly 0% to full within 90 minutes. The Life Warmer Charger has two colored LED lights to inform the provider of the status of charge and condition of the battery.The Quantum Battery Charger connects to the Battery via an omni-directional plug that allows for rapid energy transfer while prioritizing safety even in cases of hasty disconnection. The Quantum Battery will alert the user if there is any issue associated with the health of the battery. The Charger comes supplied with a 6-foot AC power cord.

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More Product Details

Catalog Number

35-0002

Brand Name

Life Warmer Quantum Charger

Version/Model Number

63-5905

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K181775

Product Code Details

Product Code

BSB

Product Code Name

Warmer, Blood, Non-Electromagnetic Radiation

Device Record Status

Public Device Record Key

1254da1b-3439-43e6-8085-7f4f0aea1a28

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

September 03, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFE WARMER INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7