HRW
12 FDA 510(k) clearances · Product code
18 daysmedian time to decision
53 days90th percentile
12clearances measured
FDA profile
- Official device name
- Dynamometer, Nonpowered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.1250
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 1992: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| JTECH COMMANDER AND ALGOMETER (K971407) | J-Tech Medical, Inc. | 1998-04-20 |
| DIGIT-GRIP WITH LCD (DGR002) (K970870) | Nk Biotechnical Corp. | 1997-05-02 |
| LIGHTSCOPE SET (K894557) | Optik | 1989-08-07 |
| HANDHELD DYNAMOMETER, MODEL #160 AND #111 (K861396) | Spark Instruments & Academics, Inc. | 1986-05-02 |
| PINCH GAUGE, 0-301 LBS. (K821631) | Fred Sammons, Inc. | 1982-06-11 |
| PINCH METER (K812343) | Fred Sammons, Inc. | 1981-09-11 |
| BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG (K801719) | Fred Sammons, Inc. | 1980-08-04 |
| MUSCLE TESTING GUN (K791021) | The Orthodyn Co. | 1979-06-15 |
| PRESSURE MONITOR, MODEL 212 (K790302) | Zatek | 1979-03-21 |
| DYNAMETER 50 LB. (K772415) | Fred Sammons, Inc. | 1978-01-05 |
| PINCH GUAGE (K772413) | Fred Sammons, Inc. | 1978-01-05 |
| JAMAR DYNAMOMETEO BK-7498 (K771288) | Fred Sammons, Inc. | 1977-07-21 |
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Every clearance here is in the API, with alerts when new ones post.