FDA.reportPublic FDA data

AquafirmeXS

Primary DI
06970441320132
Brand
AquafirmeXS
Company
Beijing Anchorfree Technology Co., Ltd.
Model
AquafirmeXS
Published
2025-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970441320132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970441320132069704413201326970441320132

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held electric massagerAn electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529187417
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970441320125Ultra+Ultra+2025-08-20
06970441320019AnchorfreeL8082016-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088095244976843H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244976913H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977073H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977143H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977213H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977383H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977453H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977523H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244976773H Smart Massage Bed3H, Co., LtdISA2026-07-28
00810140063106Renpho Massage GunJoicom CorporationISA2026-07-21
00810140063076RenphoJoicom CorporationISA2026-06-23
06972433811246JermeiShenzhen Jermei Medical Device Technology Co.,LtdISA2026-06-10
00850071298017Smart-RSTHyperion Medical Technologies, Inc.ISA2026-06-02
16973368290059MedisanaZhangzhou Easepal Medical Science And Technology Co., Ltd.ISA2026-04-30
07630039101855MASTERPULS®Storz Medical AGISA2026-04-15
00045915831424Human TouchHuman Touch, LLCISA2026-01-12
00045915831431Human TouchHuman Touch, LLCISA2026-01-12
00045915831448Human TouchHuman Touch, LLCISA2026-01-12
00045915831455Human TouchHuman Touch, LLCISA2026-01-12
00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
00197344153605MEDLINEMEDLINE INDUSTRIES, INC.ISA2025-10-17
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.ISA2025-07-15
00810140061355RENPHOJoicom CorporationISA2024-11-19
00810140061362RENPHOJoicom CorporationISA2024-11-19
00074108453488CONAIRCONAIR CORPORATIONISA2024-10-07