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Battery Pack S1009LA

by Portable Power Systems, Inc.

510(k) K933065

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK933065 Date17 Feb 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Battery Pack S1009LA is a rechargeable power source designed to supply electrical energy to portable medical devices. Classified under product code DPS, it is intended for use in cardiovascular-related applications, providing consistent power output for extended durations.

This device is supplied as a reusable unit and has received FDA 510(k) clearance under the Traditional pathway, with a decision date of February 17, 1994. It is not specified as single-use or sterile, and no MRI safety information is provided. The device is regulated under the Cardiovascular advisory committee and is manufactured by Portable Power Systems, Inc.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is this battery pack designed for one-time use or can it be recharged and reused over time?

    The Battery Pack S1009LA is explicitly described as a reusable unit, meaning it is intended for repeated use after recharging rather than single-use disposal. Since it is rechargeable and not labeled as sterile or single-use, it is meant to power portable medical devices over extended periods without replacement.

  • What types of medical devices is this battery pack intended to power, and how long can it provide consistent power?

    This battery pack is classified under product code DPS and is intended for cardiovascular-related applications, supplying consistent electrical energy to portable medical devices for extended durations. While the exact runtime isn’t specified, its design emphasizes reliability for prolonged use in such applications.

  • How is this battery pack regulated, and which committee reviewed its submission?

    The Battery Pack S1009LA received FDA 510(k) clearance under the Traditional pathway and was reviewed by the Cardiovascular (CV) Advisory Committee. The submission was filed on June 22, 1993, and cleared on February 17, 1994, with a determination of Substantially Equivalent (SESE) to a predicate device.

  • Is this battery pack sterile, and if not, what considerations should be taken when handling it?

    The Battery Pack S1009LA is not specified as sterile, meaning it is not intended for direct patient contact in a sterile environment. Since it is reusable, proper cleaning and maintenance protocols should be followed to ensure safe, repeated use without compromising performance or hygiene.