Jain Insulating Boot Model 225B

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

510(k) Number

K822652 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the Jain Insulating Boot Model 225B used for in a clinical setting?

  The Jain Insulating Boot Model 225B is a reusable component of an implantable pacemaker system designed to generate and deliver electrical impulses for cardiac pacing. It helps maintain proper heart function by stimulating contractions when the heart’s natural pacemaker is not functioning correctly, making it suitable for patients requiring temporary or permanent cardiac rhythm management.

• How is the Jain Insulating Boot Model 225B supplied and handled to ensure sterility?

  This device is intended for use in sterile environments like an operating room or electrophysiology lab. Since it is a reusable component of a pacemaker system, it must be handled according to the manufacturer’s guidelines to preserve sterility and functionality before and after each use.

• Is the Jain Insulating Boot Model 225B a single-use or reusable device?

  The Jain Insulating Boot Model 225B is explicitly described as a reusable component within a pacemaker system. It is not intended for single-use and must be maintained according to manufacturer instructions to ensure proper function and sterility across multiple procedures.

• What regulatory pathway was followed for the FDA clearance of the Jain Insulating Boot Model 225B?

  The device was cleared through the FDA’s 510(k) pathway, specifically under a traditional review process, and was determined to be substantially equivalent to a predicate device. The clearance number is K822652, and it falls under the Cardiovascular specialty with regulation number 870.3610.

• What medical specialty is primarily responsible for using the Jain Insulating Boot Model 225B?

  The Jain Insulating Boot Model 225B is classified under the Cardiovascular medical specialty, indicating its primary use in procedures related to heart rhythm management and pacing systems. Clinicians in cardiology or electrophysiology would typically handle or prescribe its use.