510(k) K251958

Device: VEINOPLUS Back
Applicant: Dynapulse Medical
510(k) number: K251958
Product code: NUH
Decision: Substantially Equivalent (SESE)
Decision date: 2025-12-23
Date received: 2025-06-25
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: N

Related Records

Applicant Contact

Contact: Steffen Magnell
Address: 13500 Wayzata Blvd. Minnetonka MN US 55305 55305

FDA Registration Numbers

3003895865
3014774380
3011050674
3004146401
3010402752
3004264602
3008585473
1528161
3012651177
3008729899
3033881629
3026164517
3012176966
3010162782
3030597665
8040537
3011564440
3008929787
3011120089
3012386142
3012446970
3017450375
3007731000
3043013796
3027241812
3026264
2023152
3010485091
2000004234
3012725363
3012729332
3009437400
3017264244
1450057
3011267903
3017887847
3003740945
3030539046
3007543044
8030245
3010405397
3005170249
3006367638
3015142815
3009488655
3003255790
3018940143
3016452327
3014344342
3019822804
3005569927
3012316249
3002669614
2013558
3030412027
3030220267
3033847811
3007710601
3014601569
3038195193
3028172072
3012500350
3023237645
3023339107
3018514222
3021422553
1832894
3032062344
3007719656
3008973759
3033530347
3013957847
3038295706
9615033
3004541594
3011191255
2939821
3013671142
3003741676
3027062656

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code NUH

510(k)	Device	Applicant	Decision date
K253896	TENS/EMS device (GUSE01)	Globalcare Medical Technology Co., Ltd.	2026-03-04
K253305	TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)	Shenzhen Jiantuo Electronics Co., Ltd.	2025-12-31
K253740	TENS&EMS (HZ9151B, HZ9151C, HZ9151D)	Hong Qiangxing (Shenzhen) Electronics Limited	2025-12-23
K252688	Transcutaneous Electrical Nerve Stimulator (RJTENS-2)	Bozhou Rongjian Medical Appliance Co., Ltd.	2025-11-24
K251856	Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4	Everyway Medical Instruments Co.,Ltd	2025-11-21
K243131	Triathlon Pro	Sigma Biomedical	2025-11-07
K251429	OTC 4-Channel Rechargeable TENS Unit	Changsha Anxiang Medical Technology Co., Ltd.	2025-08-28
K250784	Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)	Shenzhen Yicai Health Technology Co., Ltd.	2025-08-21
K251187	3 in 1 TENS UNIT (TC1241, TC2241, TS1241)	Changsha Anxiang Medical Technology Co., Ltd.	2025-07-28
K243856	TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)	Shenzhen Astec Technology Co., Ltd.	2025-05-29
K250360	TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)	Shenzhen Jiantuo Electronics Co., Ltd.	2025-05-11
K250053	TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)	Shenzhen Jiantuo Electronics Co., Ltd.	2025-05-09
K243613	Patch-TEA (Model TRI-21)	Transtimulation Research, Inc.	2025-04-09
K250033	Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)	Guangzhou Pinzhi Medical Technology Co., Ltd.	2025-04-07
K242460	Progenix Select Stim	Progenix, LLC	2025-04-02