StacksVerified U.S. regulatory reference

21 CFR §870.3670

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable pacemaker.
  2. (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.