MUSCLE TESTING GUN
FDA 510(k) clearance K791021 · decided 1979-06-15
Clearance details
- K-number
- K791021
- Device name
- MUSCLE TESTING GUN
- Applicant
- The Orthodyn Co.
- Decision
- Substantially Equivalent
- Date received
- 1979-05-30
- Decision date
- 1979-06-15
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- HRW
- Device class
- 1
- Regulation number
- 888.1250
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.