← Product Code [LBB](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB) · K923964

# NK GRASP SENSOR, MODEL GA001 (K923964)

_Nk Biotechnical Engineering Co. · LBB · May 12, 1993 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94diagnostic-devices/LBB/K923964

## Device Facts

- **Applicant:** Nk Biotechnical Engineering Co.
- **Product Code:** [LBB](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LBB.md)
- **Decision Date:** May 12, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.1240
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory 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.

## Special Controls

*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.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94diagnostic-devices/LBB/K923964](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94diagnostic-devices/LBB/K923964)

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