MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)

• K Number: K964933
• Device Name: MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)
• Manufacturer: MEKANIKA, INC.
• Date Cleared: 1997-02-03 ( 55 days)
• Product Code: LBB
• Regulation Number: 888.1240

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

Predicate Devices

N/A

Reference Devices

N/A

AI/ML (Artificial Intelligence / Machine Learning)

N/A

Therapeutic

N/A

Diagnostic

N/A

SaMD (Software as a Medical Device)

N/A

IVD (In Vitro Diagnostic)

N/A

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

N/A

Regulation Number and Section

§ 888.1240 AC-powered dynamometer.

(a)
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.(b)
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.

Summary

N/A