FDA.reportPublic FDA data

NESS H200® Wireless Hand Rehabilitation System

Primary DI
07290110482008
Brand
NESS H200® Wireless Hand Rehabilitation System
Company
BIONESS INC.
Model
H2W-5300
Catalog number
501-00037-01
Device description
H200 Wireless US System kit, Right Medium
Published
2017-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPFStimulator, muscle, powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123636000H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICEBioness, Inc.2013-05-01GZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110482008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110482008072901104820087290110482008

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Degrees Celsius
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97297907100info@bioness.co.il

Regulatory Flags#

DUNS number
182287727
Device count
1
DM exempt
true
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815962021464StimRouter User KitST2-50502022-10-17
00815962020528H200 Wireless SystemH2W-53002019-08-08
00815962020535H200 Wireless SystemH2W-52002019-08-08
00815962020542H200 Wireless SystemH2W-55002019-08-08
00815962020559H200 Wireless SystemH2W-54002019-08-08
00815962020566H200 Wireless SystemH2W-40002019-08-08
00815962020573H200 Wireless SystemH2W-41002019-08-08
00815962020580H200 Wireless SystemH2W-51002019-08-08
00815962020597H200 Wireless SystemH2W-50002019-08-08
00815962020603H200 Wireless SystemH2W-47002019-08-08
07290110482015NESS H200® Wireless Hand Rehabilitation SystemH2W-5200501-00038-012017-02-02
07290110482022NESS H200® Wireless Hand Rehabilitation SystemH2W-5500501-00041-012017-02-02
07290110482039NESS H200® Wireless Hand Rehabilitation SystemH2W-5400501-00042-012017-02-02
07290110482046NESS H200® Wireless Hand Rehabilitation SystemH2W-4000501-00094-012017-02-02
07290110482053NESS H200® Wireless Hand Rehabilitation SystemH2W-4100501-00095-012017-02-02
07290110482060NESS H200® Wireless Hand Rehabilitation SystemH2W-5100501-00120-012017-02-02
07290110482077NESS H200® Wireless Hand Rehabilitation SystemH2W-5000501-00121-012017-02-02
07290110482084NESS H200® Wireless Hand Rehabilitation SystemH2W-4700501-00176-012017-02-02
00815962020290H200 WirelessH2W-SW012018-02-08
00815962020511H200 Wireless SystemH2W-5D002019-06-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
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06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-03
08809851470145WavefacialWEERO Co., Ltd.IPF2026-06-22
G345SL2000CIONICCionic, Inc.IPF2026-06-04
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
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03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
04048223122235Stim2GoPajunk GmbH MedizintechnologieIPF2026-05-21
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
00816864021682accufitMETTLER ELECTRONICS CORP.IPF2026-04-22
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
00714905117649Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00810140062680RENPHOJoicom CorporationIPF2025-10-20
00810140062697RENPHOJoicom CorporationIPF2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.IPF2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.IPF2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.IPF2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.IPF2025-09-11
00810113683379DualPulse CompactManamed, Inc.IPF2025-09-11