Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart B — Diagnostic Devices](/submissions/OR/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 888.1250](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/888.1250) → HRW — Dynamometer, Nonpowered

# HRW · Dynamometer, Nonpowered

_Orthopedic · 21 CFR 888.1250 · Class 1_

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

## Overview

- **Product Code:** HRW
- **Device Name:** Dynamometer, Nonpowered
- **Regulation:** [21 CFR 888.1250](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/888.1250)
- **Device Class:** 1
- **Review Panel:** [Orthopedic](/submissions/OR)

## Identification

A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip muscle strength of a patient's hand.

## Classification Rationale

Class I. The device is exempt from the premarket notification procedures in subpart E of part 807.

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K971407](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRW/K971407.md) | JTECH COMMANDER AND ALGOMETER | J-Tech Medical, Inc. | Apr 20, 1998 | SESE |
| [K970870](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRW/K970870.md) | DIGIT-GRIP WITH LCD (DGR002) | Nk Biotechnical Corp. | May 2, 1997 | SESE |
| [K894557](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRW/K894557.md) | LIGHTSCOPE SET | Optik | Aug 7, 1989 | SESE |
| [K861396](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRW/K861396.md) | HANDHELD DYNAMOMETER, MODEL #160 AND #111 | Spark Instruments & Academics, Inc. | May 2, 1986 | SESE |
| [K821631](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRW/K821631.md) | PINCH GAUGE, 0-301 LBS. | Fred Sammons, Inc. | Jun 11, 1982 | SESE |
| [K812343](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRW/K812343.md) | PINCH METER | Fred Sammons, Inc. | Sep 11, 1981 | SESE |
| [K801719](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRW/K801719.md) | BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG | Fred Sammons, Inc. | Aug 4, 1980 | SESE |
| [K791021](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRW/K791021.md) | MUSCLE TESTING GUN | The Orthodyn Co. | Jun 15, 1979 | SESE |
| [K790302](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRW/K790302.md) | PRESSURE MONITOR, MODEL 212 | Zatek | Mar 21, 1979 | SESE |
| [K772415](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRW/K772415.md) | DYNAMETER 50 LB. | Fred Sammons, Inc. | Jan 5, 1978 | SESE |
| [K772413](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRW/K772413.md) | PINCH GUAGE | Fred Sammons, Inc. | Jan 5, 1978 | SESE |
| [K771288](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRW/K771288.md) | JAMAR DYNAMOMETEO BK-7498 | Fred Sammons, Inc. | Jul 21, 1977 | SESE |

## Top Applicants

- Fred Sammons, Inc. — 6 clearances
- J-Tech Medical, Inc. — 1 clearance
- Nk Biotechnical Corp. — 1 clearance
- Optik — 1 clearance
- Spark Instruments & Academics, Inc. — 1 clearance

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

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