FDA.reportPublic FDA data

Small applicator

Primary DI
B108899AP2C2MUS00
Brand
Small applicator
Company
BTL INDUSTRIES LIMITED
Model
899-AP-C-2
Published
2021-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NGXStimulator, Muscle, Powered, For Muscle Conditioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B108899AP2C2MUS00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Deep-tissue electromagnetic stimulation system, professionalAn assembly of devices designed to apply an electromagnetic (EM) field to body tissues to: 1) treat musculoskeletal disorders (e.g., osteoarthritis, osteoporosis); 2) treat body pain (musculoskeletal, postsurgical); 3) help facilitate soft and hard tissue wound/injury healing; and/or 4) reduce subcutaneous fat layers by muscle stimulation. It includes an electrically-powered control unit and application pads/flat coils intended to emit EM radiation to the treatment site. It is not intended to apply an electric current directly to the body nor produce therapeutic deep heat. The system is intended to be used in a clinical setting only.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
733532951
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B108499AP1MRA1MUS00Large applicator499-AP-MRA-12026-10-20
B108499AP1MRA2MUS00Small applicator499-AP-MR-22026-10-20
B108499AP1MRA45MUS00Edge applicators499-AP-MRA-4, 499-AP-MRA-52026-10-20
B108499PO1MUS00BTL-499-1BTL-499-12026-10-20
B108890APMMUS00EMFACE controllerBTL-785-72026-10-12
B108890APSMUS00EXION Face applicatorBTL-785-22026-10-12
B108398AP1MA3MUS00Chair Applicator398-AP-MA-32026-08-27
B108398PO11MUS00EMSELLA DUOEMSELLA DUO2026-08-27
B108890POAMUS00BTL-890UBTL-890U2026-08-26
B108699APM1MUS00EXOMIND Dual applicatorBTL-699-AP-M-12026-08-25
B108660POMUS00R-GAITR-GAIT2026-03-19
B108899PO11C1ENUS0150EMSCULPT NEOEMSCULPT NEO2024-09-23
B108043POEMVMUS00EMVITALEMVITAL2025-11-19
B108451APHFAMUS00EMVITAL Hands-Free ApplicatorEMVITAL Hands-Free Applicator2025-11-19
B108785APMMUS10EMFACE controllerBTL-785-72023-06-28
B108699PO3M2MUS00BTL-699 EXOMINDBTL-699 EXOMIND2025-04-04
B108699BELTMEU00BeltBelt2024-11-06
B108699HEADRESTMEU00HeadrestHeadrest2024-11-06
B108699APM2MUS00EXOMIND applicatorBTL-699-AP-M-22024-08-28
B108699PO2M2MUS00EXOMINDEXOMIND2024-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850092200006PEPPERPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200013PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200020PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200037PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200044PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200051PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200068PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200075PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200082PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200099PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200105PepperPEPPER INTERACTIVE INC.NGX2026-10-05
06978452680160ZoksiShenzhen Jiantuo Electronics Co., LtdNGX2026-09-03
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNGX2026-08-26
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNGX2026-08-18
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-08-17
00850085485106AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-08-17
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-29
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-25
00850080988657AUVONUAN HEALTHCARE LIMITEDNGX2026-07-22
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-09
00850080988572AUVONUAN HEALTHCARE LIMITEDNGX2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-03
06978452680122AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-07-01
00850085485021AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-26