510(k) K813226
- Device
- GEL FLOTATION MATTRESS
- Applicant
- JEFFERSON INDUSTRIES, INC.
- 510(k) number
- K813226
- Product code
- IKY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-12-02
- Date received
- 1981-11-10
- Regulation
- 880.5150
- Classification name
- Mattress, Flotation Therapy, Non-powered
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- 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#
- 3033790380
- 3004116007
- 3009402404
- 3034694976
- 3009525805
- 3029836575
- 3003542872
- 3030266256
- 3029923680
- 8043965
- 3005179379
- 3015526491
- 3001124136
- 3006802326
- 3001584105
- 3003770834
- 3007029061
- 3015286905
- 3042941605
- 1528695
- 3007378235
- 3035224824
- 3007842980
- 9615019
- 3043051314
- 3010579827
- 3008058231
- 2032476
- 3012363901
- 9616144
- 3008775647
- 1043615
- 3012316249
- 8030607
- 2182536
- 3009327812
- 3021907521
- 3035380696
- 1528759
- 3002798200
- 1824206
- 2435947
- 3002668219
- 1832066
- 3006697241
- 3043460907
- 1834244
- 3007582653
- 3011191255
- 3011687503
- 3011776382
- 3015772781
- 3032252823
- 3010394125
- 1836047
- 3009008046
- 3006365764
- 3013564718
- 3034728569
- 3044519507
- 1041130
- 3030519472
- 2438690
- 3017171467
- 3010409218
- 1419181
- 3009488612
- 3008791328
- 3014220748
- 3018101395
- 3042129334
- 3007734888
- 3004194020
- 3018084435
- 1226711
- 3045857735
- 3008146946
- 3007220726
- 3033506545
- 3017860524
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IKY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914921 | SCM-3 AND ACCESSORIES | Gaymar Industries, Inc. | 1992-03-12 |
| K802781 | BEDDING PADS EGGCREATE PADS | Leemart Bedding Mfg. Co. | 1980-12-10 |
| K802833 | TETRA NATAL-MAT WATER FLOTATION MAT. | Tetra Group U.S.A., Inc. | 1980-12-10 |
| K780779 | ECONO-FLOAT WATER FLOTATION MATTRESS | Jefferson Industries, Inc. | 1978-05-19 |
| K772062 | NEONATAL FLOTATION SYSTEM | Medpro, Inc. | 1977-11-15 |
| K771824 | MEDPRO FLOTATION SYSTEM | Medpro, Inc. | 1977-10-19 |
| K760963 | DECUBITUS MATTRESS | Arco Medical Products Co. | 1976-11-18 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases