FDA product code HRW: Dynamometer, Nonpowered
HRW is the FDA product code for dynamometer, nonpowered. It is a Class I device, regulated under 21 CFR 888.1250 and reviewed by the Neurology panel. FDA has cleared 12 510(k) submissions under HRW, from 7 different applicants. The average 510(k) review took 51 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Dynamometer, Nonpowered |
| Device class | Class I |
| Regulation | 21 CFR 888.1250 |
| Review panel | NE — Neurology |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HRW clearance
Top HRW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 6 | 1982-06-11 |
| J-Tech Medical, Inc. | 1 | 1998-04-20 |
| Nk Biotechnical Corp. | 1 | 1997-05-02 |
| Optik | 1 | 1989-08-07 |
| Spark Instruments & Academics, Inc. | 1 | 1986-05-02 |
2 more applicants have HRW clearances. See the full list in Caduvo.
Most recent HRW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971407 | J-Tech Medical, Inc. | JTECH COMMANDER AND ALGOMETER | 1998-04-20 | 369 |
| K970870 | Nk Biotechnical Corp. | DIGIT-GRIP WITH LCD (DGR002) | 1997-05-02 | 53 |
| K894557 | Optik | LIGHTSCOPE SET | 1989-08-07 | 18 |
| K861396 | Spark Instruments & Academics, Inc. | HANDHELD DYNAMOMETER, MODEL #160 AND #111 | 1986-05-02 | 17 |
| K821631 | Fred Sammons, Inc. | PINCH GAUGE, 0-301 LBS. | 1982-06-11 | 8 |
Recalls for HRW devices
openFDA lists no recalls for product code HRW.
Frequently asked questions
What is FDA product code HRW?
HRW is the FDA product code for dynamometer, nonpowered. It is a Class I device, regulated under 21 CFR 888.1250 and reviewed by the Neurology panel.
What device class is HRW?
Class I, regulation 21 CFR 888.1250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HRW?
Across 12 cleared submissions the average was 51 days from receipt to decision (median 18).
Which companies have the most HRW clearances?
Fred Sammons, Inc. (6); J-Tech Medical, Inc. (1); Nk Biotechnical Corp. (1); Optik (1); Spark Instruments & Academics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HRW
- Run a recall and safety report across every HRW manufacturer
- Watch product code HRW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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