Product code GZJ— Neurology
ALPHA-STIM 350
- Classification name
- Stimulator, Nerve, Transcutaneous, For Pain Relief
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Total cleared
- 606
- First cleared
- Most recent
Market context for product code GZJ
FDA has cleared devices under product code GZJ between 1976 and 2026, filed by 324 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code GZJ
Recent clearances under product code GZJ
1–100 of 606- K252712 — STIMPOD NMS460 Nerve Stimulator
- K252767 — actiTENS mini
- K252236 — CP Relief Wand Rx - TENS/NMES
- K232441 — Unipro (K-UNIPRO-US)
- K241228 — TENSWave
- K233046 — Electrical Neuromuscular Stimulator, Cure Trio
- K222879 — Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
- K212618 — iRelieve Microcurrent Pain Relief System
- K213802 — StimOnTM Pain Relief System (GM2439)
- K220578 — Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
- K220503 — TENS device-EmeTerm 2, Model: YF-ZTY-E2
- K202893 — Transcutaneous Electrical Nerve Stimulator
- K202186 — TrueRelief Device
- K210202 — BioWaveGO RX
- K201458 — Scrambler Therapy Technology (Model ST-5A)
- K202159 — actiTENS
- K201431 — OGYILI TENS/NMES Stimulator
- K181645 — StimaWELL 120MTRS
- K191547 — ReliefBand
- K182960 — ReliefBand
- K182025 — ClearUP Sinus Pain Relief
- K180943 — BioWaveGO
- K172478 — TENS device-EmeTerm, CinvStop
- K173233 — ReliefBand 1.5
- K161091 — STIMPOD NMS460 Nerve Stimulator
- K162663 — WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A
- K160246 — SimulCare II(TM)
- K153704 — Strive
- K152676 — FD TENS 2090, FD TENS 2095
- K152437 — BiowaveHOME Neuromodulation Pain Therapy Device
- K143198 — Synapse Transcutaneous Electrical Stimulation Device
- K142666 — Scrambler Therapy MC-5 A Device
- K131513 — SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
- K133779 — CP RELIEF WAND
- K123099 — Best-AV2 Pro-Sport(tm)
- K131675 — BODIHEALTH SYSTEM
- K123958 — JIAJIAN POINTOSELECT DIGITAL
- K130919 — SENSUS
- K122948 — GEM-STIM COMBO STIMULATOR
- K121369 — NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR
- K121305 — STERLING MEDICAL IMPULSE 3 STIMULATOR
- K120398 — WITOUCH PRO
- K121184 — SENSUS
- K121578 — ATOM 1 (MODEL: BRC 2200)
- K113544 — ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
- K120569 — GEMORE TENS SYSTEM
- K120054 — ULTIMA NEO
- K112288 — JIAJIAN TENS
- K111654 — FD TENS 2070
- K112258 — NEUROTECH PLUS
- K112485 — H-WAVE
- K111645 — FD TENS 2050 OR SLIDE TENS MODEL FD2050
- K102278 — QUADRA BLOC TENS PLUS
- K110350 — KNEEHAB XP
- K110390 — ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR
- K100668 — NEMA-ST, MODEL V1.0.2
- K102014 — TENS STIMULATOR, MODELS 2800 AND 3000
- K100399 — 4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A
- K092117 — SCENAR, MODEL 10
- K092448 — HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
- K091045 — SMART TENS, MODEL: D-BC05T
- K092990 — AMD 6605 TENS/NMES
- K090866 — NEUROCALM MODEL 1 AND 2
- K083250 — NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
- K091236 — MANTRA COMBO, MODEL MECS 320
- K091317 — LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK
- K090922 — EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR
- K090717 — FLEX-TENS
- K083822 — LASER TOUCHONE
- K081835 — ACTICARE IC AND TSE
- K082190 — BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298
- K082057 — DX6605E-TENS, DX6605E-G, DX6609-G
- K081255 — SCRAMBLER ST 5 TENS DEVICE
- K082377 — TENSCARE ITOUCH MODEL(S) EASY AND PLUS
- K083030 — TENS-EMS-14
- K083494 — ULTIMA FIVE
- K083202 — COMBOCARE 2000
- K082011 — MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
- K082514 — TENS/EMS COMBO, EMS, TENS
- K080221 — EA STIMULATOR
- K081141 — COMBOCARE 2000
- K080304 — PRO TENS, MODEL WL-240 RX
- K071120 — AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999
- K073008 — KFH ENERGY, MODEL: E1
- K071869 — TENS/IF 14
- K073438 — PROSTIM 1000/2000
- K072123 — HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE
- K071878 — DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB
- K071624 — EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR
- K062003 — NEURO WAVE 6
- K071951 — COMFY SERIES: EV-804, EV-805 & EV-806
- K061828 — LORENZ BIOTECH APTIVA, VERSION 2.13
- K070299 — EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)
- K062616 — WELLNESSPRO 2010
- K062641 — BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1
- K070474 — NEWLIFE SCIENCES LLC, MODEL TMR
- K062547 — QUADRA BLOC TENS, MODEL 101
- K052836 — BODIHEALTH SYSTEM
- K061516 — STAODYN MAX PRESET, MODEL 4470
- K061650 — SELECT TENS, MODEL 4600S
Data sourced from openFDA. This site is unofficial and independent of the FDA.