Product Code: HRW
FDA class 1
21 CFR 888.1250
Dynamometer, Nonpowered
Orthopedic
A nonpowered dynamometer is a mechanical measuring instrument used in orthopedic assessment to quantify muscular strength or grip force without requiring an external power source. It is classified as an FDA Class 1 device under 21 CFR 888.1250, indicating minimal risk and general controls only. Product code HRW falls under the Orthopedic medical specialty.
510(k)s
12
FEI Numbers
46
Registration Numbers
46
Unique Applicants
7
Years Active
21
Basic Information
- Product Code
- HRW
- Device Class
- FDA class 1
- Regulation Number
- 888.1250
- Medical Specialty
- Orthopedic
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K971407 | JTECH COMMANDER AND ALGOMETER | Apr 20, 1998 | Substantially Equivalent | J-Tech Medical, Inc. |
| K970870 | DIGIT-GRIP WITH LCD (DGR002) | May 02, 1997 | Substantially Equivalent | Nk Biotechnical Corp. |
| K894557 | LIGHTSCOPE SET | Aug 07, 1989 | Substantially Equivalent | Optik |
| K861396 | HANDHELD DYNAMOMETER, MODEL #160 AND #111 | May 02, 1986 | Substantially Equivalent | Spark Instruments & Academics, Inc. |
| K821631 | PINCH GAUGE, 0-301 LBS. | Jun 11, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K812343 | PINCH METER | Sep 11, 1981 | Substantially Equivalent | Fred Sammons, Inc. |
| K801719 | BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG | Aug 04, 1980 | Substantially Equivalent | Fred Sammons, Inc. |
| K791021 | MUSCLE TESTING GUN | Jun 15, 1979 | Substantially Equivalent | The Orthodyn Co. |
| K790302 | PRESSURE MONITOR, MODEL 212 | Mar 21, 1979 | Substantially Equivalent | Zatek |
| K772415 | DYNAMETER 50 LB. | Jan 05, 1978 | Substantially Equivalent | Fred Sammons, Inc. |
| K772413 | PINCH GUAGE | Jan 05, 1978 | Substantially Equivalent | Fred Sammons, Inc. |
| K771288 | JAMAR DYNAMOMETEO BK-7498 | Jul 21, 1977 | Substantially Equivalent | Fred Sammons, Inc. |
FEI Numbers
This FDA classification entry is associated with 46 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 46 registration numbers. Click on an entry to view related FDA registrations.