510(k) K963677
- Device
- 9th Wave Model 200 Alternating Pressure Pad
- Applicant
- 9TH WAVE, INC.
- 510(k) number
- K963677
- Product code
- FNM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-11-26
- Date received
- 1996-09-13
- Regulation
- 880.5550
- Classification name
- Mattress, Air Flotation, Alternating Pressure
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEAN ROZINT
- Address
- P.O. Box 1026 Mt Pleasant SC US 29465 29465
FDA Registration Numbers#
- 3037012186
- 3015173212
- 3012274425
- 3015526491
- 3031582440
- 3008146946
- 3009342468
- 3004475699
- 3007005431
- 9616471
- 3019502344
- 1644196
- 1320918
- 3012084379
- 3013440654
- 2921578
- 3036113193
- 3013548496
- 3011714211
- 3015772781
- 3006802326
- 3010785927
- 3009307988
- 3012841710
- 3005179379
- 3029836575
- 3005619970
- 3010526655
- 3010394125
- 8043439
- 3003574554
- 3005720080
- 3038188186
- 3012392312
- 9710603
- 3007420694
- 3008058231
- 3009402404
- 3004526603
- 3030681105
- 3003801933
- 3011539161
- 3013545943
- 3009955851
- 3014264913
- 3017642731
- 2435947
- 3013524663
- 3016678950
- 3005182235
- 1531186
- 3011659880
- 3004082002
- 3005687730
- 3038191348
- 3011687503
- 3012453539
- 3030019986
- 1000252066
- 3009525805
- 3015219192
- 8022890
- 1041130
- 3021269058
- 3008386649
- 1043644
- 3016678414
- 3010373263
- 3012316249
- 2438690
- 3010588638
- 3008351005
- 3009567010
- 3014293077
- 1417592
- 2085249
- 3043460907
- 3015058854
- 3014542717
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FNM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K973169 | PRESSURE GUARD SITE SELECT (A) | Span-America Medical Systems, Inc. | 1998-02-20 |
| K974319 | MIGHTY AIR | Wheelchairs of Kansas | 1998-01-22 |
| K972022 | ZAK-2000 | Cardio Systems, Inc. | 1998-01-22 |
| K974070 | PHYSIO/1000 | Physio Designs, Inc. | 1998-01-06 |
| K972549 | SIMPULSE | Kinetic Concepts, Inc. | 1997-11-18 |
| K970081 | SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM | Cathay Consolidated, Inc. | 1997-11-07 |
| K955243 | BARIAIR | Kinetic Concepts, Inc. | 1997-10-23 |
| K970468 | KT AIR BED | Kinetic Concepts, Inc. | 1997-09-05 |
| K965207 | RID-DECUBE II | Skin Care Management, Inc. | 1997-08-21 |
| K972153 | ALTERNATING PRESSURE AIR FLOTATION MATTRESS | Decubiti Concepts, Inc. | 1997-07-31 |
| K971568 | REST MATTRESS | Rest Mattress | 1997-07-18 |
| K954320 | MODIFIED PEDIKAIR | Kinetic Concepts, Inc. | 1997-07-18 |
| K970362 | CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM | Apex Metal, Inc. | 1997-05-16 |
| K970428 | REST X SYSTEM | Restxsys | 1997-05-14 |
| K970350 | EQUI-PISE 1000 MRS | Advanced Air Support Consultancy, Inc. | 1997-04-22 |