---
kind: "section"
citation: "21 C.F.R. § 870.5225"
title: "21"
number: "870.5225"
heading: "External counter-pulsating device."
url: "https://uscodex.org/cfr/21/870.5225"
---

# §870.5225. External counter-pulsating device.

- (a) **Identification.** An external counter-pulsating device is a noninvasive, prescription device used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle.
- (b) **Classification.**
  - (1) Class II (special controls) when the device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. The special controls for this device are:
    - (i) Nonclinical performance evaluation of the device must demonstrate a reasonable assurance of safety and effectiveness for applied pressure, synchronization of therapy with the appropriate phase of the cardiac cycle, and functionality of alarms during a device malfunction or an abnormal patient condition;
    - (ii) Reliabilities of the mechanical and electrical systems must be established through bench testing under simulated use conditions and matched by appropriate maintenance schedules;
    - (iii) Software design and verification and validation must be appropriately documented;
    - (iv) The skin-contacting components of the device must be demonstrated to be biocompatible;
    - (v) Appropriate analysis and testing must be conducted to verify electrical safety and electromagnetic compatibility of the device; and
    - (vi) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to use of the device.
  - (2) **Class III (premarket approval) for the following intended uses—** Unstable angina pectoris; acute myocardial infarction; cardiogenic shock; congestive heart failure; postoperative treatment of patients who have undergone coronary artery bypass surgery; peripheral arterial disease associated with ischemic ulcers rest pain or claudication, threatened gangrene, insufficient blood supply at an amputation site, persisting ischemia after embolectomy or bypass surgery, and/or pre- and post-arterial reconstruction to improve runoff; diabetes complicated by peripheral arterial disease or other conditions possibly related to arterial insufficiency including nocturnal leg cramps and/or necrobiosis diabeticorum; venous diseases, including prophylaxis of deep vein thrombophlebitis, edema (e.g., chronic lymphedema) and/or induration (e.g., stasis dermatitis) associated with chronic venous stasis, venous stasis ulcers, and/or thrombophlebitis; athletic injuries, including Charley horses, pulled muscles and/or edematous muscles; necrotizing cellulitis.
- (c) **Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required.** A PMA or notice of completion of a PDP is required to be filed with FDA on or before March 31, 2014, for any external counter-pulsating device, with an intended use described in [paragraph (b)(2)](#b-2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any external counter-pulsating device, with an intended use described in [paragraph (b)(2)](#b-2) of this section, that was in commercial distribution before May 28, 1976. Any other external counter-pulsating device with an intended use described in [paragraph (b)(2)](#b-2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

## Notes

### Amendments

[78 FR 79307, Dec. 30, 2013]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

### Amendments

[78 FR 79307, Dec. 30, 2013]