510(k) K950085
- Device
- MULTICURE(R) S GEL PAD
- Applicant
- MULTIGESTION (DEUTSCHLAND) GMBH
- 510(k) number
- K950085
- Product code
- KIC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-07-13
- Date received
- 1995-01-10
- Regulation
- 890.3175
- Classification name
- Cushion, Flotation
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- FRANCOIS-XAVIER WEISS
- Address
- Lebuis/Latour Du Pin Saint Victor De Gessieu FR
FDA Registration Numbers#
- 2937137
- 3010894709
- 3013198248
- 3010729057
- 3030539818
- 3031606416
- 3013545943
- 3021283042
- 3009955851
- 3010588638
- 3039359026
- 2023711
- 1059079
- 1000649241
- 3014301546
- 3005885000
- 3004462857
- 3004475699
- 1832066
- 3008466086
- 3007220726
- 3010694026
- 3007744208
- 8030607
- 3006803771
- 3010394125
- 3016170451
- 1000357070
- 3009327812
- 3004365956
- 1043615
- 3017488851
- 3011137372
- 3012643605
- 3024102
- 3006803543
- 3012363901
- 2030595
- 3008630266
- 9710603
- 3043460907
- 3007791604
- 3005037196
- 8022890
- 3012464408
- 3007309299
- 9615543
- 3004727093
- 3040389283
- 3003965134
- 3015772781
- 3008562183
- 3029923680
- 3009492409
- 9710020
- 3030522263
- 3034694939
- 8043439
- 3014674312
- 9616471
- 3011706862
- 3010785927
- 9615410
- 3012466243
- 1220351
- 3038632739
- 3045752480
- 2028253
- 3015220641
- 3005533818
- 9615350
- 3045925755
- 3010182295
- 1954156
- 3015337148
- 3011852752
- 3005273623
- 1320918
- 3013379460
- 3011526299
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KIC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960189 | GEL-T CUSHION | Span-America Medical Systems, Inc. | 1996-02-07 |
| K953352 | PROTEAM CUSHION | Iskra.Med | 1995-11-29 |
| K954117 | CUSTOMCARE SEATING SYSTEM | Span-America Medical Systems, Inc. | 1995-10-13 |
| K945667 | MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION | Micos Medical Systems | 1995-02-21 |
| K941858 | GEL CUSHION | Hollister, Inc. | 1994-05-05 |
| K911843 | ZERO-G(TM) GEL/FOAM MATTRESS TOPPER | Steridyne Corp. | 1991-05-30 |
| K872739 | SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION | D.A. Schulman, Inc. | 1987-07-30 |
| K864108 | PUSH CUSH | Medical Industries America, Inc. | 1986-11-14 |
| K864109 | C' AIRECUSH SEAT CUSHION | Medical Industries America, Inc. | 1986-11-14 |
| K861327 | ROHO HEEL PAD | Roho, Inc. | 1986-06-02 |
| K855072 | MAXIMUS CUSHION | Jay Medical, Ltd. | 1986-03-10 |
| K851814 | WHEELCHAIR CUSHIONS | Dignicare | 1985-07-09 |
| K851027 | SOF. CARE CUSHION & SOF-CARE CUSHION COVER | Gaymar Industries, Inc. | 1985-06-18 |
| K842380 | PRESSURE RELIEF SEAT CUSHION | American Pharmaseal Div. Ahsc | 1984-06-28 |
| K842120 | ZERO-G | Steridyne Corp. | 1984-06-08 |
Legacy Summary#
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FDA Review#
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