Battery Charger, 171 Pacemaker

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

510(k) Number

K782162 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• What types of pacemakers can this battery charger support for recharging?

  This battery charger is designed specifically for recharging the batteries of implantable pacemaker pulse-generators compatible with the 171 series. It is intended for use with pacemakers that rely on rechargeable battery systems to maintain cardiac rhythm management in patients with bradycardia or conduction disorders. Always verify compatibility with your specific pacemaker model before use.

• Is this device intended for use in outpatient clinics, or is it strictly for hospital settings?

  The charger is intended for clinical settings, such as hospitals or cardiac care facilities, where trained personnel can operate and maintain it. While not explicitly restricted to hospitals, its design and regulatory classification (Class III) suggest it is best suited for environments with proper calibration, cleaning protocols, and staff trained in pacemaker systems.

• How is this device cleaned and maintained between uses, and is it reusable?

  This battery charger is a reusable medical device and is not sterile. Between uses, it requires proper cleaning and calibration to ensure safety and performance. The manufacturer’s instructions (not provided here) should outline specific maintenance procedures, but standard practices for reusable medical devices—such as disinfection and periodic servicing—would apply.

• Does this charger have any special storage requirements, such as temperature or humidity controls?

  The device data does not specify storage conditions, but as a reusable medical device used in clinical settings, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s guidelines (not detailed here) to prevent damage to electrical components or calibration accuracy.

• What regulatory pathway was followed for this device’s approval, and how does that affect its use?

  This device received FDA 510(k) clearance (K782162) under the Traditional pathway, with a substantially equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee. This means it meets FDA safety and performance standards for Implantable Pacemaker Pulse-Generators (Class III device). The clearance ensures compliance with 21 CFR 870.3610, but clinical use remains dependent on proper training and adherence to the manufacturer’s instructions.