Ob Help Arm
FDA 510(k) K823152 · Orthion Corp.
510(k) numberK823152
Submission
- Device name
- Ob Help Arm
- Applicant
- Orthion Corp.
Mchenry, IL, US - Received
- October 20, 1982
- Decision date
- November 5, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ILE – Sling, Arm, Overhead Supported
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Specialty
- Physical Medicine
Other 510(k)s with product code ILE
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| K832546 | Mark V High Voltage Galvanic StimulatorrIPF · Traditional | 10/14/1983SE |
| K823156 | Collapsable Lavatory HeightenerILS · Traditional | 11/05/1982SE |
| K823155 | Lavatory Seat HeightenerILS · Traditional | 11/05/1982SE |
| K823154 | Shower Stool W/HandlesIKX · Traditional | 11/05/1982SE |
| K823153 | Bath Tub Seat & Bath BoardIKX · Traditional | 11/05/1982SE |
| K823151 | Ob Tripp Transport ChairINM · Traditional | 11/05/1982SE |
| K823150 | Sesam Treatment TableINQ · Traditional | 11/05/1982SE |
| K823149 | Ob Tilt TableINW · Traditional | 11/05/1982SE |
| K823105 | Resi-WalkerITJ · Traditional | 11/05/1982SE |
| K812701 | Ortho-Therm Infrared SensorIYM · Traditional | 10/13/1981SE |
Questions and answers
When was Ob Help Arm cleared by the FDA?
Ob Help Arm (K823152) received a 510(k) decision of Substantially Equivalent on November 5, 1982, 16 days after the submission was received.
What is the product code of K823152?
The FDA product code is ILE – Sling, Arm, Overhead Supported, a Class I (low risk) device regulated under 21 CFR 890.3475.