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Alexander Manufacturing Co. Rechargeable Battery STR5

by Alexander Mfg. Co.

510(k) K971107

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 NumberK971107 Date5 Jun 1997ClearedStatusActive

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  • Withdrawn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)

Full name
Alexander Manufacturing Co. Rechargeable Battery Part Number STR5
510(k) Number
FDA Product Code
BTA
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is a rechargeable battery designed as a power source for portable, powered aspiration pumps. It provides the necessary electrical energy to operate suction devices used in medical settings, ensuring continuous functionality for procedures requiring fluid removal or airway clearance.

The battery is supplied as a standalone component, intended for use with compatible aspiration pumps. It is not sterile and is classified as a reusable device, requiring recharging between uses. The device holds an FDA 510(k) clearance (K971107) under regulatory classification BTA, with no specific MRI safety restrictions noted. Storage and handling follow standard battery protocols to maintain performance and longevity.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Alexander STR5 rechargeable battery used for?

    The Alexander STR5 rechargeable battery serves as the power source for portable, powered aspiration pumps. These pumps are used in medical settings to remove fluids or clear airways during procedures, ensuring continuous operation when connected to this battery.

  • Is the STR5 battery sterile and how is it supplied?

    The STR5 battery is not sterile and is supplied as a standalone component. It is intended for use with compatible aspiration pumps and is designed to be reused after recharging between uses.

  • How is the STR5 battery recharged and maintained?

    The STR5 battery is a rechargeable device, meaning it requires periodic recharging to restore its electrical capacity for continued use. Proper storage and handling—following standard battery protocols—are essential to maintain performance and longevity over multiple recharging cycles.

  • What types of aspiration pumps is the STR5 battery compatible with?

    The STR5 battery is designed for use with portable, powered aspiration pumps, specifically those categorized under FDA product code BTA (Pump, Portable, Aspiration). Compatibility depends on the manufacturer’s specifications for the pump model, as listed in the device’s regulatory submissions.

  • Are there any MRI safety restrictions for the STR5 battery?

    The STR5 battery has no specific MRI safety restrictions noted in its regulatory documentation. However, standard precautions for batteries and electronic devices should still be followed when used in or near MRI environments to avoid interference or damage.