510(k) K073361
- Device
- MUSCLE PAIN DEVICE (MPD)
- Applicant
- Stevens Proof of Concept, Inc.
- 510(k) number
- K073361
- Product code
- IPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-03-18
- Date received
- 2007-11-30
- Regulation
- 890.5850
- Classification name
- Stimulator, Muscle, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- JECKIN D SHAH
- Address
- 68 Southfield Ave. Suite 100-2 Stamford Landing Stamford CT US 06902 06902
FDA Registration Numbers#
- 8022189
- 3007543044
- 3010805941
- 3038197172
- 3019892999
- 3043012074
- 3008525454
- 3014315574
- 3011767724
- 3017263740
- 3012386142
- 3033847811
- 3013917867
- 3012651177
- 3004076349
- 3012352782
- 3013069546
- 3005095860
- 1644243
- 3011782009
- 3004509773
- 3004264602
- 3027718340
- 3003895865
- 3023330992
- 3043012240
- 3016512343
- 3016087653
- 3004413879
- 1528161
- 3004733458
- 3012168464
- 3029312829
- 3023339107
- 3001676837
- 3012316249
- 8040537
- 3015619973
- 3005868392
- 3005569927
- 1055808
- 3003740945
- 3045753434
- 3038138457
- 3013671142
- 2013558
- 3011905669
- 3009538657
- 3004183512
- 3005783425
- 3007502541
- 3013508647
- 3008008477
- 9710567
- 3005545216
- 3032062344
- 3043657394
- 3017450375
- 3015529344
- 3008770252
- 3017866822
- 9611612
- 2024292
- 1930027
- 3010583453
- 3013378804
- 3025235024
- 3015452693
- 3006153348
- 3007743972
- 3003971136
- 9710582
- 9615033
- 3006850006
- 8010720
- 2011115
- 3009494725
- 3042228064
- 3017264244
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IPF#
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| K233926 | accufit | Mettler Electronics Corporation | 2024-03-21 |
| K233485 | M-Wave | Zynex Medical, Inc. | 2024-01-26 |
| K232937 | BTL-899M | BTL Industries, Inc. | 2023-12-26 |
| K230701 | Stim2Go | PAJUNK GmbH Medizintechnologie | 2023-11-24 |