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#
- 2243810
- 3001659628
- 2431499
- 3012421607
- 3038191351
- 8010507
- 9616494
- 3005906953
- 3003309160
- 3006223085
- 3015069144
- 3003772414
- 9616086
- 3006705287
- 3009718162
- 3030446844
- 3031027442
- 3038871395
- 3017910381
- 3005621376
- 3010394125
- 3012544667
- 3011542053
- 3004649387
- 3015214304
- 3004458220
- 3038191611
- 3014527909
- 3017364737
- 3038198853
- 3009555569
- 3010960892
- 3008997160
- 3014258951
- 3011706862
- 3010120748
- 3013856565
- 3009097552
- 3010267676
- 3017207289
- 2242467
- 3004839683
- 3007774549
- 3008048783
- 1424774
- 2182345
- 3003895329
- 3005885000
- 2939821
- 3017048841
- 3033849666
- 3004361921
- 1000626221
- 3039167356
- 3011654627
- 1000649241
- 3011404939
- 3021275665
- 3011219296
- 1417592
- 3012841710
- 3017417635
- 3026062712
- 3043326342
- 3032850395
- 3043050885
- 3012174974
- 3004967086
- 3003653126
- 1043591
- 1060680
- 3010097863
- 8010401
- 3005472804
- 3006707030
- 3021099366
- 3003855936
- 3033796310
- 3011094893
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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