21 CFR § 870.3670 Cardiovascular Devices

§ 870.3670 Pacemaker charger.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(a) Identification. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable pacemaker.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

← § 870.3650 Pacemaker polymeric mesh bag.§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode. →