Resi-Walker
FDA 510(k) K823105 · Orthion Corp.
510(k) numberK823105
Submission
- Device name
- Resi-Walker
- 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
- ITJ – Walker, Mechanical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3825
- Specialty
- Physical Medicine
Other 510(k)s with product code ITJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K833869 | Child's WalkerITJ · Traditional | Kaye Products, Inc. | 11/29/1983SE |
| K833195 | Umbrella WalkerITJ · Traditional | Convaid Products, Inc. | 10/27/1983SE |
| K830784 | Walk N RollITJ · Traditional | Meta-Morris | 05/25/1983SE |
| K830848 | Resi-WalkerITJ · Traditional | Lic-Orthion | 04/05/1983SE |
| K821404 | Light Weight Aluminum WalkerITJ · Traditional | Manuco Manufacturing Co., Inc. | 05/21/1982SE |
| K820711 | Walk-A-CycleITJ · Traditional | Walk-A-Cycle Division | 04/08/1982SE |
| K811485 | Walker/Crutch BagITJ · Traditional | Fred Sammons, Inc. | 06/16/1981SE |
| K792064 | Delta Rolling Self-Licking WalkerITJ · Traditional | Staricat, Inc. | 10/30/1979SE |
| K790529 | Walking AidITJ · Traditional | Maddak, Inc. | 04/03/1979SE |
| K772049 | Walking AidITJ · Traditional | Guardian Products Co., Inc. | 11/11/1977SE |
More from Guardian Products Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K823152 | Ob Help ArmILE · 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 |
| K812701 | Ortho-Therm Infrared SensorIYM · Traditional | 10/13/1981SE |
Questions and answers
When was Resi-Walker cleared by the FDA?
Resi-Walker (K823105) 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 K823105?
The FDA product code is ITJ – Walker, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3825.