HRW · Dynamometer, Nonpowered
Orthopedic · 21 CFR 888.1250 · Class 1
Overview
| Product Code | HRW |
|---|---|
| Device Name | Dynamometer, Nonpowered |
| Regulation | 21 CFR 888.1250 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
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.
Cleared Devices (12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971407 | JTECH COMMANDER AND ALGOMETER | J-Tech Medical, Inc. | Apr 20, 1998 | SESE |
| K970870 | DIGIT-GRIP WITH LCD (DGR002) | Nk Biotechnical Corp. | May 2, 1997 | SESE |
| K894557 | LIGHTSCOPE SET | Optik | Aug 7, 1989 | SESE |
| K861396 | HANDHELD DYNAMOMETER, MODEL #160 AND #111 | Spark Instruments & Academics, Inc. | May 2, 1986 | SESE |
| K821631 | PINCH GAUGE, 0-301 LBS. | Fred Sammons, Inc. | Jun 11, 1982 | SESE |
| K812343 | PINCH METER | Fred Sammons, Inc. | Sep 11, 1981 | SESE |
| K801719 | BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG | Fred Sammons, Inc. | Aug 4, 1980 | SESE |
| K791021 | MUSCLE TESTING GUN | The Orthodyn Co. | Jun 15, 1979 | SESE |
| K790302 | PRESSURE MONITOR, MODEL 212 | Zatek | Mar 21, 1979 | SESE |
| K772415 | DYNAMETER 50 LB. | Fred Sammons, Inc. | Jan 5, 1978 | SESE |
| K772413 | PINCH GUAGE | Fred Sammons, Inc. | Jan 5, 1978 | SESE |
| K771288 | JAMAR DYNAMOMETEO BK-7498 | Fred Sammons, Inc. | Jul 21, 1977 | SESE |
Top Applicants
- Fred Sammons, Inc. — 6 clearances
- Zatek — 1 clearance
- The Orthodyn Co. — 1 clearance
- Spark Instruments & Academics, Inc. — 1 clearance
- Optik — 1 clearance
