← Back to catalogue

R&D Batteries, Inc. Part Numbers 5039, 5052, 5056 and 5061

FDA 510(k)

Class II (US FDA 510(k))

510(k) K951282

by R & D Batteries, Inc.

Identifiers

510(k) Number
K951282 FDA 510(k)
FDA Product Code
FLL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2910 FDA 510(k)
Regulation Number
880.2910 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a battery system identified by part numbers 5039, 5052, 5056, and 5061, manufactured by R&D Batteries, Inc. It is a medical device that received FDA 510(k) clearance under K951282, with a decision of substantially equivalent to a predicate device. The product code is FLL, and it was reviewed by the General Hospital advisory committee (HO).

The device was cleared via the traditional 510(k) pathway, with the application received on March 21, 1995, and a decision date of August 18, 1995. It is authorized for distribution in the United States, manufactured at 400 Gateway Blvd., Burnsville, MN 55337. No third-party review was involved in the clearance process.

Frequently asked questions

What is the R&D Batteries part numbers 5039, 5052, 5056, and 5061 device used for?

This device is a battery system designed for medical applications, providing power to compatible medical equipment as part of a cleared medical device system under FDA 510(k) pathway.

How is the R&D Batteries part numbers 5039, 5052, 5056, and 5061 supplied and is it sterile or single-use?

The device is supplied as a non-sterile, reusable battery system; it is not intended for single-use and does not require sterilization as it is an external power source not in direct patient contact.

What sizes or models are available for the R&D Batteries part numbers 5039, 5052, 5056, and 5061?

The device is identified by four specific part numbers: 5039, 5052, 5056, and 5061, each representing a distinct configuration within the same battery system family manufactured by R&D Batteries, Inc.

What are the storage requirements for the R&D Batteries part numbers 5039, 5052, 5056, and 5061?

While specific storage conditions are not detailed in the provided data, as a battery system it should be stored in a cool, dry environment according to standard battery handling practices to maintain performance and safety.

What regulatory pathway was used for the R&D Batteries part numbers 5039, 5052, 5056, and 5061 device?

The device received FDA 510(k) clearance via the traditional pathway, with application received March 21, 1995, and clearance granted August 18, 1995, under K951282, determined substantially equivalent to a predicate device.

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: R&D Batteries, Inc. Part Numbers 5039, 5052, 5056 and 5061, R&D Batteries, Inc. Part Numbers 5039, 5052, 5056 and 5061, PDF K951282 R&D Batteries, Inc. Part Numbers 5039, 5052, 5056 and 5061, fda.innolitics.com, R&D Batteries 5052 BATTERY Replacement Lithium Battery

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
R & D Batteries, Inc.

Sources (1)

  • FDA 510(k) K951282 24 fields · synced Sep 21, 2026