510(k) K231569

Device: ManaFlexx 2 (model: MF002-RX, MF002-OTC)
Applicant: Manamed, Inc.
510(k) number: K231569
Product code: NUH
Decision: Substantially Equivalent (SESE)
Decision date: 2023-11-03
Date received: 2023-05-31
Regulation: 882.5890
Classification name: Stimulator, Nerve, Transcutaneous, Over-The-Counter
Medical specialty: Neurology
Review panel: Neurology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Trevor Theriot
Address: 5240 W. Charleston Blvd., Suite 150 Las Vegas NV US 89146 89146

FDA Registration Numbers

3020769982
3012446970
3039394880
2249769
1832894
3015619973
8022077
3007710601
3033530347
3028172072
3022631685
3007615436
3012729332
3001373226
3006469120
9616877
3032062344
3010852191
3038295706
3026753375
3006852037
3015214304
3014601569
3006626283
3009494725
3042190125
3008048783
3003741676
3002669614
3015588280
3013957847
2248223
3017887928
3038311114
1055808
3006367638
3006850006
3010894709
3013671142
3011412151
3008573045
3009888740
3015007456
2024292
3022929665
3008011951
3014314933
3007731000
3001224205
9616086
3027241812
3026322014
3005621440
3010078417
3025235024
3008973759
3004264602
3007689716
3010770433
8030245
3018514222
3023330992
3012386142
3026164517
3008929787
3003255790
3011050674
3009437400
1450057
3008806536
3014647250
3003740945
3010485091
3018109879
3010880718
3012725363
3010328269
9611558
3007543044
3026264

Source Documents

510(k) summary PDF

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