510(k) K831690
- Device
- IPOS ANTI-ADDUCTUS SHOE
- Applicant
- IPOS LUNEBURG
- 510(k) number
- K831690
- Product code
- KNP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-06-24
- Date received
- 1983-05-24
- Regulation
- 890.3475
- Classification name
- Orthosis, Corrective Shoe
- 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#
- 3007774549
- 3008264083
- 3006755899
- 3043326342
- 1000626221
- 3010703418
- 3008808082
- 3005663580
- 1424774
- 3012544667
- 3014861961
- 3030446844
- 3039303185
- 3004898984
- 3032564317
- 3021099366
- 3038871395
- 3012421607
- 3032850395
- 3006074162
- 3008997160
- 3011094904
- 3006705287
- 2431499
- 3005621376
- 1000649241
- 3001084743
- 3021443431
- 3018565643
- 3019252654
- 3005037196
- 3034735163
- 2243810
- 3034694939
- 3035382630
- 3011404939
- 3005718816
- 3015134013
- 3006543248
- 3013527364
- 3017633586
- 3006264697
- 3035493200
- 3033796310
- 2242467
- 3011219296
- 3042871618
- 3030128625
- 3042226212
- 3042227943
- 3003898328
- 3007084179
- 3003998208
- 3012453779
- 3029785246
- 3017910381
- 3033859618
- 8010401
- 3015459201
- 3035530544
- 3010982802
- 3005752995
- 3012480144
- 3014943293
- 3009285151
- 3033519146
- 3008579854
- 3011053188
- 3008483430
- 3007125287
- 1121034
- 3021275665
- 3011526299
- 3027604498
- 3013856565
- 9615543
- 3038191351
- 3012772427
- 3014258951
- 3005083016
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KNP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K831552 | SORBOTHANE VISCO INNER SOLE PAD | Fred Sammons, Inc. | 1983-06-08 |
| K823654 | SLIP-ON SANDALS FOR MEASURING SHORTNESS | Fred Sammons, Inc. | 1983-01-21 |
| K823665 | ROTATION BOOT | Warm & Form, Orthopedic Materials | 1982-12-30 |
| K810228 | SORBOTHANE | Hamilton Kent | 1981-02-10 |
| K801743 | PLASTAZOTE SHOE | Alimed, Inc. | 1980-08-07 |
| K790326 | DRUSHOE | J.E. Hanger & Co. , Ltd. | 1979-02-26 |
Legacy Summary#
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FDA Review#
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