510(k) K111557
- Device
- X-FORCE
- Applicant
- SEVEN SEAS DISTRIBTION AND MANUFACTURING LLC
- 510(k) number
- K111557
- Product code
- NYN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-11-10
- Date received
- 2011-06-03
- Regulation
- 882.5890
- Classification name
- Stimulator, Electrical, Transcutaneous, For Arthritis
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK IOELE
- Address
- 2620 S Maryland Pkwy. Suite 14 Unit 835 Las Vegas NV US 89109 89109
FDA Registration Numbers#
- 3008507279
- 3006850006
- 3012725363
- 3010328269
- 2031823
- 9617486
- 2013558
- 3007543044
- 3013671142
- 3012446970
- 3030539046
- 3011562129
- 3008573045
- 3012316249
- 3015619973
- 3033847811
- 8022077
- 3010402752
- 3021422553
- 2000004234
- 3028172072
- 3007731000
- 3003741676
- 3017264244
- 9616086
- 3007615436
- 3027241812
- 1528161
- 3010405397
- 3010097863
- 3001373226
- 8040537
- 3010078417
- 3011564440
- 3032062344
- 3010852191
- 3008585473
- 3027383626
- 3038295706
- 3005170249
- 3006852037
- 3025367760
- 3005569927
- 3011767724
- 3007689716
- 3023339107
- 3010770433
- 9615033
- 8030245
- 3011191255
- 3004049909
- 3009494725
- 3026164517
- 3003255790
- 3008048783
- 3003740945
- 3011120089
- 3004146401
- 3009437400
- 3016508547
- 3009411292
- 1450057
- 3011077581
- 3015588280
- 3012651177
- 3013378804
Source Documents#
Other 510(k) Records For Product Code NYN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142236 | BioniCare Hand System | Vision Quest Industries, Inc. | 2015-03-23 |
| K073386 | JOINT STIM, MODEL 1000 | Pain Management Technologies | 2008-07-30 |
| K062325 | RS-4I MUSCLE STIMULATOR FAMILY | Rs Medical | 2007-04-13 |
| K052625 | BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 | Bionicare Medical Technologies, Inc. | 2005-12-05 |
| K030332 | MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 | Bionicare Medical Technologies, Inc. | 2003-06-06 |
| K983228 | BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 | Murray Electronics | 1999-03-15 |
| K971437 | BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000 | Murray Electronics | 1997-07-22 |
Legacy Summary#
summary
FDA Review#
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