Goniometer, Nonpowered
This device is a nonpowered goniometer used to measure the range of motion of joints, such as the knee, elbow, or shoulder, providing objective data to support rehabilitation assessment and orthopedic evaluation. It is classified as FDA Class 1, indicating low risk, subject to general controls only. The product code is KQW, regulated under 21 CFR 888.1520 within the Orthopedic specialty. No special flags apply.
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Basic Information
- Product Code
- KQW
- Device Class
- FDA class 1
- Regulation Number
- 888.1520
- Medical Specialty
- Orthopedic
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K926237 | O'BRIEN GONIOMETER | Aug 02, 1993 | Substantially Equivalent | Sgarlato Laboratories, Inc. |
| K901744 | DOBBHOFF(R) RETRIEVAL FORCEPS | Jul 03, 1990 | Substantially Equivalent | Biosearch Medical Products, Inc. |
| K870767 | THE (CROM) TESTER | Mar 17, 1987 | Substantially Equivalent | Twin City Surgical, Inc. |
| K850082 | HAND HELD GONIOMETER | Apr 04, 1985 | Substantially Equivalent | Chattanooga Group, Inc. |
| K831550 | FINGER BONIOMETER BK7506 | Jun 24, 1983 | Substantially Equivalent | Fred Sammons, Inc. |
| K812778 | THE TELOS EQUIPMENT | Dec 08, 1981 | Substantially Equivalent | The Telos Co. |
| K810441 | UNIVERSAL GONIMETER | Feb 27, 1981 | Substantially Equivalent | Fred Sammons, Inc. |
| K801718 | BK-7513 STAINLESS STEEL GONIOMETER | Aug 04, 1980 | Substantially Equivalent | Fred Sammons, Inc. |
| K801717 | BK-7511 BRASS GONIOMETER | Aug 04, 1980 | Substantially Equivalent | Fred Sammons, Inc. |
| K801716 | BK-7505 RADIOPAQUE GONIOMETER, 8 | Aug 04, 1980 | Substantially Equivalent | Fred Sammons, Inc. |
| K801715 | BK-7497 BULB DYNAMOMETER | Aug 04, 1980 | Substantially Equivalent | Fred Sammons, Inc. |
| K760302 | GONIOMETER, INTER. STAND. LARGE, BK7514 | Sep 08, 1976 | Substantially Equivalent | Fred Sammons, Inc. |
| K760301 | GONIOMETER, MED. INTER. STAND. BK-7512 | Sep 08, 1976 | Substantially Equivalent | Fred Sammons, Inc. |
FEI Numbers
This FDA classification entry is associated with 83 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 83 registration numbers. Click on an entry to view related FDA registrations.