510(k) K801489
- Device
- EZ ON SAFETY PONCHO
- Applicant
- SKIL-CARE CORP.
- 510(k) number
- K801489
- Product code
- KNO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-07-14
- Date received
- 1980-06-26
- Regulation
- 890.3910
- Classification name
- Accessories, Wheelchair
- 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#
- 3013473968
- 3006795832
- 3009327812
- 3017936791
- 3017059401
- 3013670646
- 3008058406
- 9615350
- 3013875443
- 3010595915
- 3021071770
- 3013495708
- 3008997160
- 3011687503
- 3012404688
- 3008771621
- 1062671
- 3009394321
- 3042871597
- 3010987649
- 3010373263
- 3015526491
- 3008990835
- 3038623066
- 3032497
- 9681385
- 3015173212
- 3010547267
- 2133465
- 3004141004
- 1000292485
- 3008386649
- 3007923118
- 3005905321
- 3010373530
- 3004967086
- 3004034546
- 3017638051
- 3010392274
- 3008651983
- 3014982520
- 2953718
- 1954573
- 3008603863
- 3010398927
- 9616873
- 3026309274
- 3012316249
- 3008958682
- 2022883
- 3013198248
- 2085336
- 3017488851
- 3030514731
- 9616091
- 3007841746
- 3037012186
- 3020282968
- 3042129334
- 3012958676
- 1531186
- 9710514
- 8022890
- 3011191255
- 1000641183
- 3010664759
- 3012411233
- 2135139
- 3031595580
- 3015946389
- 3015781799
- 9681725
- 1000406324
- 3004905643
- 2320623
- 3023189540
- 3015218514
- 2084079
- 3007963811
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KNO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K870298 | REDMAN ACCESSORIES | Redman, Inc. | 1987-02-26 |
| K823646 | FRICTION FEEDER | Fred Sammons, Inc. | 1983-01-21 |
| K823645 | VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR | Fred Sammons, Inc. | 1983-01-21 |
| K823816 | WHEELCHAIR PATIENT RESTRAINTS | Danek Medical, Inc. | 1983-01-14 |
| K823636 | ARM THROUGH FOR WHEELCHAIR BK-6459-01 & | Fred Sammons, Inc. | 1982-12-28 |
| K823635 | CUSHIONS FOR WHEELCHAIR ARMS | Fred Sammons, Inc. | 1982-12-28 |
| K823596 | CLAMP ON HOLDER FOR A GLASS OR CUP | Fred Sammons, Inc. | 1982-12-22 |
| K823595 | HEAD SUPPORT FOR WHEELCHAIR | Fred Sammons, Inc. | 1982-12-22 |
| K821642 | WHEEL CHAIR ACCESSORIES | Fred Sammons, Inc. | 1982-06-11 |
| K820964 | WHEELCHAIR PAL | Pryor Products | 1982-04-16 |
| K813627 | BK-6453 RIMMED ACRYLIC LAP TRAY KIT | Fred Sammons, Inc. | 1982-01-19 |
| K812350 | WHEELCHAIR ACCESSORIES | Fred Sammons, Inc. | 1981-09-11 |
| K811482 | INCONTINENT PAD | Fred Sammons, Inc. | 1981-08-25 |
| K811486 | WHEELCHAIR RAMPS | Fred Sammons, Inc. | 1981-06-16 |
| K811491 | WHEELCHAIR ACCESSORIES | Fred Sammons, Inc. | 1981-06-12 |
Legacy Summary#
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FDA Review#
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