21 CFR 888.1240 — Dynamometer, Ac-Powered
Orthopedic (OR) · Part 888 Subpart B—Diagnostic Devices · § 888.1240
Identification
An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LBB | Dynamometer, Ac-Powered | 2 | 36 |
Special Controls
LBB — Dynamometer, Ac-Powered
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
eCFR
