510(k) K801796
- Device
- THE COMFORT LIFT
- Applicant
- GETTNER ENTERPRISES, INC.
- 510(k) number
- K801796
- Product code
- FMR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-13
- Date received
- 1980-07-29
- Regulation
- 880.6785
- Classification name
- Device, Transfer, Patient, Manual
- 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#
- 3010388769
- 3014200467
- 3005748481
- 3031582440
- 3016674288
- 3015068387
- 3021374638
- 3018269545
- 3013641287
- 3030927791
- 3008311431
- 3038623066
- 3031916218
- 3004499949
- 1420128
- 1528440
- 3040387958
- 1836161
- 3040277471
- 3001124136
- 3005588647
- 1225263
- 3032391
- 9614609
- 2431497
- 3005831263
- 3015173437
- 3041276591
- 3001650535
- 3020460367
- 3016678950
- 3009008046
- 3005755627
- 3010373530
- 3043051314
- 3014270896
- 3019798849
- 3015288041
- 3005202231
- 3027782967
- 3038772401
- 3001644167
- 2183887
- 3007479130
- 3036731074
- 1037752
- 3013298431
- 3006123327
- 3015007646
- 2244900
- 3020163307
- 3015209701
- 3013894805
- 1824206
- 9710603
- 3013517171
- 3026848699
- 3008381107
- 3030078769
- 3007886583
- 8022590
- 1651499
- 3004777218
- 3007441619
- 3014934217
- 2024351
- 3008518417
- 3009407891
- 3011621895
- 3014982520
- 3014680784
- 3011245426
- 3007309299
- 3013675759
- 1043572
- 3010452421
- 3009567010
- 3029923680
- 3017558212
- 3017181414
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K871475 | SOLOLIFT - PATIENT TRANSFER STRETCHER | Adel Medical , Ltd. | 1987-05-11 |
| K800373 | TENDERLIFT | Competent Design | 1980-03-12 |
| K792318 | SKIL-CARE TURN AND HOLD PAD | Skil-Care Corp. | 1979-12-20 |
| K770499 | PATIENT TURNING AND REPOSITIONING G DEV. | Patient Healthguards Corp. | 1977-04-29 |
Legacy Summary#
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FDA Review#
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