510(k) K790531
- Device
- ANUS STIMULATOR
- Applicant
- MADDAK, INC.
- 510(k) number
- K790531
- Product code
- ILS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-04-26
- Date received
- 1979-03-15
- Regulation
- 890.5050
- Classification name
- Adaptor, Hygiene
- 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#
- 3021167963
- 3008997160
- 3011456684
- 3015276780
- 3031583032
- 3004126239
- 3017278503
- 3014810929
- 3006400320
- 3003770834
- 3042278063
- 1422443
- 2428983
- 3012316249
- 3004526603
- 3017555752
- 3010101089
- 3008603863
- 3019576863
- 3030539818
- 3043126945
- 3042276253
- 3029995169
- 3030226293
- 3026875457
- 3019677893
- 3017155124
- 3010147274
- 3009542966
- 3009327812
- 3012327277
- 3030452839
- 3007309323
- 3016446653
- 3043654660
- 3045058049
- 3010603857
- 3043088172
- 3014268398
- 3026818268
- 3045030500
- 3003781173
- 3003123807
- 3014273557
- 3032448714
- 3032835495
- 3004475699
- 3016426850
- 3032027168
- 1000228440
- 3023852281
- 3009282549
- 3010595915
- 8022077
- 3004905643
- 3007420694
- 3011210208
- 3043749706
- 3008386507
- 3010113803
- 3016170451
- 3015080575
- 3007082185
- 3023272778
- 3007481922
- 3038304894
- 2084079
- 3045752480
- 3036893546
- 3009481053
- 3009955851
- 3027643666
- 3043127556
- 3008410069
- 9710117
- 3009703478
- 1417592
- 3033814356
- 3013600135
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ILS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K852049 | MEDICAL TOILET SEAT | Pedro Aleman | 1985-06-24 |
| K842651 | COMMODE CHAIR 98200 | Guardian Products Co., Inc. | 1984-08-07 |
| K830853 | LAVATORY SEAT HEIGHTENER | Lic-Orthion | 1983-06-08 |
| K831547 | RAISED TOILET SEATS & NAIL CLIPPERS | Fred Sammons, Inc. | 1983-06-08 |
| K830425 | TOILET SEAT RAISED | Maddak, Inc. | 1983-05-09 |
| K830852 | SHOWER STOOL W/HANDLES | Lic-Orthion | 1983-04-05 |
| K823641 | BATHING CHAIR FOR CHILD | Fred Sammons, Inc. | 1983-01-21 |
| K823626 | DISPOSABLE TOOTH BRUSH | Fred Sammons, Inc. | 1982-12-30 |
| K823606 | PLASTIC BREAK RESISTANT MIRROR | Fred Sammons, Inc. | 1982-12-28 |
| K823155 | LAVATORY SEAT HEIGHTENER | Orthion Corp. | 1982-11-05 |
| K823156 | COLLAPSABLE LAVATORY HEIGHTENER | Orthion Corp. | 1982-11-05 |
| K821860 | BK-6477 THE DERBY RAISED TOILET SEAT | Fred Sammons, Inc. | 1982-07-02 |
| K821638 | HYGIENE ADAPTORS | Fred Sammons, Inc. | 1982-06-11 |
| K821009 | BATHTUB GRAB BAR | Guardian Products Co., Inc. | 1982-04-21 |
| K813635 | CHILDS TOILET TRAINER HYGIENE AIDS | Fred Sammons, Inc. | 1982-01-19 |
Legacy Summary#
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FDA Review#
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