510(k) K823105
- Device
- RESI-WALKER
- Applicant
- ORTHION CORP.
- 510(k) number
- K823105
- Product code
- ITJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-11-05
- Date received
- 1982-10-20
- Regulation
- 890.3825
- Classification name
- Walker, Mechanical
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007123908
- 3010603857
- 3016598690
- 3030233125
- 3032027168
- 1422443
- 3012271517
- 1060680
- 3013495708
- 3008997160
- 3008771621
- 3009952786
- 3019502344
- 3021244191
- 3010373263
- 3008990835
- 3010675897
- 3012521614
- 3009107702
- 3038304894
- 1000292485
- 3008386649
- 1931307
- 3010461764
- 3009096107
- 3033849261
- 3008651983
- 3009560891
- 3016678414
- 3005214422
- 3012316249
- 3031284260
- 3012579728
- 3016426850
- 3027847726
- 9710514
- 3005878604
- 3011191255
- 3039346864
- 3012444100
- 3034629632
- 3011962812
- 3015781799
- 3015058854
- 3009495988
- 3016678950
- 3036978609
- 3016661538
- 3027520367
- 1523547
- 3010967704
- 3007019343
- 9611956
- 3032448714
- 8022865
- 3015698523
- 3001657382
- 9680900
- 3004594214
- 3013530901
- 3007160937
- 3015005470
- 1417592
- 3043460907
- 3043127556
- 3009567010
- 3004132709
- 3007791489
- 3014336266
- 3017181414
- 1319061
- 3014983822
- 3014204628
- 3019505063
- 3016000960
- 3005037196
- 3004194020
- 3007905163
- 3006123327
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ITJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K833869 | CHILD'S WALKER | Kaye Products, Inc. | 1983-11-29 |
| K833195 | UMBRELLA WALKER | Convaid Products, Inc. | 1983-10-27 |
| K830784 | WALK N ROLL | Meta-Morris | 1983-05-25 |
| K830848 | RESI-WALKER | Lic-Orthion | 1983-04-05 |
| K821404 | LIGHT WEIGHT ALUMINUM WALKER | Manuco Manufacturing Co., Inc. | 1982-05-21 |
| K820711 | WALK-A-CYCLE | Walk-A-Cycle Division | 1982-04-08 |
| K811485 | WALKER/CRUTCH BAG | Fred Sammons, Inc. | 1981-06-16 |
| K792064 | DELTA ROLLING SELF-LICKING WALKER | Staricat, Inc. | 1979-10-30 |
| K790529 | WALKING AID | Maddak, Inc. | 1979-04-03 |
| K772049 | WALKING AID | Guardian Products Co., Inc. | 1977-11-11 |
| K770417 | ANIMATOR | Kdk Medical Products | 1977-04-15 |
| K770608 | WALKING AID | Will Ross Co. | 1977-04-08 |
| K770166 | MANOY WALKING AID | Maddak, Inc. | 1977-01-28 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases