21 CFR 870.3670 — Charger, Pacemaker
Cardiovascular (CV) · Part 870 Subpart D—Cardiovascular Prosthetic Devices · § 870.3670
Identification
A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable pacemaker.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KRF | Charger, Pacemaker | 1 | 0 |
