FDA.reportPublic FDA data

BodyMed

Primary DI
20815991023013
Brand
BodyMed
Company
BOXOUT, LLC
Model
ZZACOMBO
Catalog number
ZZACOMBO
Device description
BODYMED TENS/EMS/MASSAGER COMBO
Published
2019-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K181688000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181688000R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorShenzhen Roundwhale Technology Co. , Ltd.2018-09-07IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815991023016PackageGS11In Commercial Distribution
20815991023013PackageGS132In Commercial Distribution
00815991023019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081599102301610815991023016
2081599102301320815991023013
00815991023019008159910230198159910230190815991023019

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-528-2152info@bodysportproducts.com

Regulatory Flags#

DUNS number
066689993
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815991024405BodyMedBDMNEBCOM2022-07-01
00815991024412BodyMedBDMNEBDOG2022-07-01
00815991025167BodyMedBDMNEBCOMREU2025-07-17
00815991024047BodyMedBDMNTRGVMEDBDMNTRGVMED2024-12-04
00815991024054BodyMedBDMNTRGVSMBDMNTRGVSM2024-12-04
00815991024061BodyMedBDMNTRGVXLGBDMNTRGVXLG2024-12-04
00815991024078BodyMedBDMNTRGVXSBDMNTRGVXS2024-12-04
00815991024030BodyMedBDMNTRGVLRGBDMNTRGVLRG2024-12-04
20815991024041BodyMedBDMNTRGVMEDBDMNTRGVMED2024-12-04
20815991024058BodyMedBDMNTRGVSMBDMNTRGVSM2024-12-04
20815991024065BodyMedBDMNTRGVXLGBDMNTRGVXLG2024-12-04
20815991024072BodyMedBDMNTRGVXSBDMNTRGVXS2024-12-04
00815991025181BodyMedBDMPULSEOXBDMPULSEOX2024-10-11
20815991025185BodyMedBDMPULSEOXBDMPULSEOX2024-10-11
00815802010122BodyMedZZHP1427ZZHP14272016-09-05
00815802010139BodyMedZZHP1414ZZHP14142016-09-05
00815802010146BodyMedZZHP147ZZHP1472016-09-05
00815802010153BodyMedZZHP832UZZHP832U2016-09-05
00815802018715BodyMedZZHP1427BLKZZHP1427BLK2016-08-01
00815991022623BodyMedZZHPS1623ZZHPS16232019-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G345SL2000CIONICCionic, Inc.IPF2026-06-04
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
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
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.IPF2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.IPF2025-08-21
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
00810188050052L360 Thigh SystemBioness Medical, Inc.IPF2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.IPF2025-07-18
00810188050441H200 Wireless SystemBioness Medical, Inc.IPF2025-07-18
00810188050076L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050106L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050144L300 Go SystemBioness Medical, Inc.IPF2025-07-17