FDA.reportPublic FDA data

H200 Wireless

Primary DI
00810188050601
Brand
H200 Wireless
Company
Bioness Medical, Inc.
Model
H2W-SW01
Device description
Clinician Programmer Software for H200 Wireless System
Published
2025-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZIStimulator, Neuromuscular, External Functional

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111767000NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KITNess-Neuromuscular Electrical Stimulation Systems2011-09-15GZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815962020290PreviousGS10
00810188050601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815962020290008159620202908159620202900815962020290
00810188050601008101880506018101880506010810188050601

GMDN Terms#

Term, Definition table
TermDefinition
Hand orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus intended to be used to encompass the whole or part of the hand to support, align, prevent, or correct deformities/injuries or to improve function of the hand. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)211-9136info@bionessmedical.com

Regulatory Flags#

DUNS number
119378513
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810188050014Vector Gait and Safety SystemVEC-10002025-07-18
00810188050021Bioness Integrated System (BITS) Bedside ConfigurationBIT-21242025-07-18
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBIT-31552025-07-18
00810188050052L360 Thigh SystemL4T-60002025-07-18
00810188050083L300 Go SystemLG4-51002025-07-18
00810188050120L300 Go SystemL4P-50012025-07-18
00810188050175L100 Go SystemLG1-5X002025-07-18
00810188050274L300 Go SystemLG4-10002025-07-18
00810188050441H200 Wireless SystemH2W-5D002025-07-18
00810188050557Vector BaseVEC-30002025-07-18
00810188050038Bioness Integrated System (BITS) Mobile ConfigurationBIT-22242025-07-17
00810188050069L360 Thigh SystemL4T-60012025-07-17
00810188050076L300 Go SystemLG4-50002025-07-17
00810188050090L300 Go SystemLG4-5U002025-07-17
00810188050106L300 Go SystemLG4-5V002025-07-17
00810188050113L300 Go SystemL4P-51002025-07-17
00810188050137L300 Go SystemL4T-50002025-07-17
00810188050144L300 Go SystemL4T-50012025-07-17
00810188050168L100 Go SystemLG1-5Y002025-07-17
00810188050236L300 Go SystemL4P-5D002025-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970670070242XFTShenzhen XFT Medical LimitedGZI2026-04-14
06970670070259XFTShenzhen XFT Medical LimitedGZI2026-04-14
00852184003670Motor Point Probe, Synchrony Synapse Biomedical, Inc.GZI2025-10-31
00852184003694Electrode Cable, SingleSynapse Biomedical, Inc.GZI2025-10-31
00852184003700Electrode Cable, DualSynapse Biomedical, Inc.GZI2025-10-31
00852184003717Electrode Cable, TripleSynapse Biomedical, Inc.GZI2025-10-31
00852184003724Electrode Cable, Four Synapse Biomedical, Inc.GZI2025-10-31
00852184003762Electrode Cable KitSynapse Biomedical, Inc.GZI2025-10-31
00852184003786Sensor Boot SetSynapse Biomedical, Inc.GZI2025-10-31
00852184003793Sensor Boot - SmallSynapse Biomedical, Inc.GZI2025-10-31
00852184003809Sensor Boot - MediumSynapse Biomedical, Inc.GZI2025-10-31
00852184003816Sensor Boot - LargeSynapse Biomedical, Inc.GZI2025-10-31
00852184003649Clinical Kit, SynchronySynapse Biomedical, Inc.GZI2025-10-23
00852184003656Stimulator, SynchonySynapse Biomedical, Inc.GZI2025-10-23
00852184003663Sensor, SynchonySynapse Biomedical, Inc.GZI2025-10-23
00852184003687Patient Kit, SynchronySynapse Biomedical, Inc.GZI2025-10-23
00852184003779Kit, Wireless Charger USA 5WSynapse Biomedical, Inc.GZI2025-10-23
00860011699309EvoWalkEvolution Devices, Inc.GZI2025-08-06
00810188050052L360 Thigh SystemBioness Medical, Inc.GZI2025-07-18
00810188050083L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050120L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050274L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050441H200 Wireless SystemBioness Medical, Inc.GZI2025-07-18
00810188050069L360 Thigh SystemBioness Medical, Inc.GZI2025-07-17
00810188050076L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050090L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050106L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050113L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050137L300 Go SystemBioness Medical, Inc.GZI2025-07-17