Hand Held Goniometer
FDA 510(k) K850082 · Chattanooga Group, Inc.
510(k) numberK850082
Submission
- Device name
- Hand Held Goniometer
- Applicant
- Chattanooga Group, Inc.
Red Bank, TN, US - Received
- January 10, 1985
- Decision date
- April 4, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQW – Goniometer, Nonpowered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.1520
- Specialty
- Orthopedic
Other 510(k)s with product code KQW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K926237 | O'Brien GoniometerKQW · Traditional | Sgarlato Laboratories, Inc. | 08/02/1993SE |
| K901744 | Dobbhoff(R) Retrieval ForcepsKQW · Traditional | Biosearch Medical Products, Inc. | 07/03/1990SE |
| K870767 | The (Crom) TesterKQW · Traditional | Twin City Surgical, Inc. | 03/17/1987SE |
| K831550 | Finger Boniometer BK7506KQW · Traditional | Fred Sammons, Inc. | 06/24/1983SE |
| K812778 | The Telos EquipmentKQW · Traditional | The Telos Co. | 12/08/1981SE |
| K810441 | Universal GonimeterKQW · Traditional | Fred Sammons, Inc. | 02/27/1981SE |
| K801718 | BK-7513 Stainless Steel GoniometerKQW · Traditional | Fred Sammons, Inc. | 08/04/1980SE |
| K801717 | BK-7511 Brass GoniometerKQW · Traditional | Fred Sammons, Inc. | 08/04/1980SE |
| K801716 | BK-7505 Radiopaque Goniometer, 8KQW · Traditional | Fred Sammons, Inc. | 08/04/1980SE |
| K801715 | BK-7497 Bulb DynamometerKQW · Traditional | Fred Sammons, Inc. | 08/04/1980SE |
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| K083140 | Compex Sport PlusNGX · Traditional | 02/09/2009SE |
| K070425 | Vitalstim ExperiaIPF · Traditional | 06/11/2007SE |
| K053223 | Triton/Tru-Trac/Tx/Triton DTS TractionITH · Traditional | 02/24/2006SE |
| K051938 | Triton/Tru-Trac/Tx Traction DevicesITH · Traditional | 09/21/2005SE |
| K040662 | Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser…ILY · Traditional | 09/08/2004SE |
| K040285 | Vectra Transportable Combo and Stim (Specialty Line Dealers); Intelect Transportable…IMG · Traditional | 04/12/2004SE |
| K031077 | Vectra Epr System and Intelect Epr SystemIMG · Traditional | 12/11/2003SE |
| K031116 | Vectra (Intelect) Epr UltrasoundIMI · Traditional | 12/03/2003SE |
Questions and answers
When was Hand Held Goniometer cleared by the FDA?
Hand Held Goniometer (K850082) received a 510(k) decision of Substantially Equivalent on April 4, 1985, 84 days after the submission was received.
What is the product code of K850082?
The FDA product code is KQW – Goniometer, Nonpowered, a Class I (low risk) device regulated under 21 CFR 888.1520.