Product code HRW
- Device name
- Dynamometer, Nonpowered
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.1250
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971407 | JTECH COMMANDER AND ALGOMETER | J-Tech Medical, Inc. | 1998-04-20 |
| K970870 | DIGIT-GRIP WITH LCD (DGR002) | Nk Biotechnical Corp. | 1997-05-02 |
| K894557 | LIGHTSCOPE SET | Optik | 1989-08-07 |
| K861396 | HANDHELD DYNAMOMETER, MODEL #160 AND #111 | Spark Instruments & Academics, Inc. | 1986-05-02 |
| K821631 | PINCH GAUGE, 0-301 LBS. | Fred Sammons, Inc. | 1982-06-11 |
| K812343 | PINCH METER | Fred Sammons, Inc. | 1981-09-11 |
| K801719 | BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG | Fred Sammons, Inc. | 1980-08-04 |
| K791021 | MUSCLE TESTING GUN | The Orthodyn Co. | 1979-06-15 |
| K790302 | PRESSURE MONITOR, MODEL 212 | Zatek | 1979-03-21 |
| K772413 | PINCH GUAGE | Fred Sammons, Inc. | 1978-01-05 |
| K772415 | DYNAMETER 50 LB. | Fred Sammons, Inc. | 1978-01-05 |
| K771288 | JAMAR DYNAMOMETEO BK-7498 | Fred Sammons, Inc. | 1977-07-21 |
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|---|---|---|---|
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| 08809513720076 | Spring Hand Dynamometer | Saehan Corporation | 2026-05-18 |
| 08809513720380 | Back-Leg-Chest Dynamometer | Saehan Corporation | 2026-05-18 |
| 08809513720038 | SAEHAN Hydraulic Hand Dynamometer | Saehan Corporation | 2026-05-18 |
| 04719846012660 | Charder | CHARDER ELECTRONIC CO., LTD. | 2026-04-29 |
| 04719846017030 | Charder | CHARDER ELECTRONIC CO., LTD. | 2026-02-11 |
| 14719846017037 | Charder | CHARDER ELECTRONIC CO., LTD. | 2026-02-11 |
| 08033390301848 | General Instrument | LIMACORPORATE SPA | 2025-06-10 |
| 08033390301855 | General Instrument | LIMACORPORATE SPA | 2025-06-10 |
| 08033390301862 | General Instrument | LIMACORPORATE SPA | 2025-06-10 |
| 08033390301879 | General Instrument | LIMACORPORATE SPA | 2025-06-10 |
| 00855170007423 | DualGrip Digital Grip Dynamometer | LAFAYETTE INSTRUMENT COMPANY, INC. | 2024-09-11 |
| 07290103039073 | One Button Response Unit | MEDOC LTD. | 2023-06-20 |
| 08033390237741 | PRIMA TT Glenoid | LIMACORPORATE SPA | 2022-12-03 |
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| 08033390109499 | NA | LIMACORPORATE SPA | 2022-09-08 |
| 08033390196123 | NA | LIMACORPORATE SPA | 2022-09-08 |
| 00840216112728 | JAMAR | Asp Global, LLC | 2022-08-09 |
| 00840216112735 | JAMAR | Asp Global, LLC | 2022-08-09 |
| 00840216112704 | JAMAR | Asp Global, LLC | 2022-04-27 |
| 00840216112667 | JAMAR | Asp Global, LLC | 2022-04-04 |
| 00840216112742 | JAMAR | Asp Global, LLC | 2022-03-18 |
| 00840216112711 | JAMAR | Asp Global, LLC | 2022-03-18 |
| 00840216112698 | JAMAR | Asp Global, LLC | 2022-03-18 |
| 00840216112681 | JAMAR | Asp Global, LLC | 2022-03-18 |
| 00840216112674 | JAMAR | Asp Global, LLC | 2022-03-18 |
| 00840216112650 | JAMAR | Asp Global, LLC | 2022-03-18 |
| 08033390109505 | Revision Femoral Stem | LIMACORPORATE SPA | 2018-09-20 |
| 07290103039059 | Algomed Computerized Pressure Algometer | MEDOC LTD. | 2016-09-24 |
| 08033390095457 | Torque Wrench | LIMACORPORATE SPA | 2016-08-31 |