21 C.F.R. § 870.3670

Current through March 31, 2024
Section 870.3670 - Pacemaker charger
(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 .

21 C.F.R. §870.3670

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