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#
- 3005532347
- 3010030809
- 3008918830
- 3007710677
- 3018115441
- 3012330365
- 3017869684
- 3003827835
- 3006535976
- 3010373530
- 1223962
- 3007886583
- 1057079
- 3010373263
- 9614609
- 3002798200
- 3007913191
- 2090040
- 3015068387
- 3004496839
- 3015007646
- 2182762
- 3036731074
- 1225473
- 3010398927
- 3011245426
- 3010380518
- 3023194188
- 3026848699
- 3014200467
- 3007479130
- 3004125670
- 3019585122
- 3030979187
- 3010452421
- 1218386
- 3001650535
- 3042276341
- 3011706862
- 3042158935
- 3008881803
- 3001124136
- 3013856565
- 3005484027
- 3030539818
- 3036978609
- 3038623066
- 1924066
- 3010359088
- 3005024024
- 3015337373
- 3015423385
- 1424774
- 3031916218
- 3001644167
- 3013298431
- 3034520
- 3019798849
- 3020282968
- 3021632322
- 3010388471
- 3017953189
- 1221921
- 1225263
- 3038772401
- 3006635905
- 8010730
- 1417592
- 3008572946
- 3020978037
- 3021374638
- 3005831263
- 3015443160
- 1824206
- 3018117722
- 3015209701
- 8021894
- 1060680
- 3014934217
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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