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#
- 3013046958
- 3017004793
- 1824206
- 3007791489
- 3015781799
- 3016678414
- 3029740428
- 1931307
- 3005720080
- 3003781173
- 3009273990
- 3003218744
- 3038772401
- 3007120364
- 3043654660
- 3033814356
- 3014172160
- 3031582440
- 3011958210
- 3017538926
- 8030607
- 8043685
- 3006897028
- 3001657382
- 3003890514
- 3006984916
- 2085249
- 3015069144
- 3013527364
- 3017278503
- 3005026814
- 3011706862
- 3016678044
- 3003829642
- 3004488394
- 3019842343
- 3032171543
- 3005878604
- 3036978609
- 3022106572
- 3030192580
- 3021966508
- 3006199389
- 3042262500
- 3044085583
- 3010461764
- 3035383330
- 3017264244
- 3007309323
- 3011191255
- 9680900
- 3027135885
- 3014658541
- 3031588965
- 3005037196
- 2133432
- 3004132709
- 3010547267
- 1000292485
- 3011475060
- 3007123908
- 3014336266
- 1833497
- 3023189540
- 3009560097
- 3008990835
- 3019677893
- 3038285044
- 3009952786
- 3030681105
- 3016170451
- 1043646
- 3013530901
- 3015286905
- 3008997160
- 3007905163
- 3010603857
- 1651499
- 3015287626
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#
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