FDA.reportPublic FDA data

Homedics

Primary DI
10031262099157
Brand
Homedics
Company
Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.
Model
BM-AC108HJ
Device description
BODY FLEX BACK STRETCHING MAT WITH HEAT
Published
2020-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10031262099157PackageGS11In Commercial Distribution
00031262099150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003126209915710031262099157
00031262099150000312620991500312620991500031262099150

GMDN Terms#

Term, Definition table
TermDefinition
Bed/chair electric massagerA mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544356011
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
00031262120243HomedicsHHP-285HJ-RD2026-01-15
06971552170739MedisanaHM 1032024-11-19
06971552170746MedisanaHM 103P2024-11-19
00031262112286HomedicsSPE-320HJ2024-10-30
00031262116369HomedicsFMS-347HJ-BK2024-10-30
00031262116420HomedicsFMS-347HJ-RD2024-10-30
00031262116482HomedicsFMS-347HJ-GY2024-10-30
00031262112453HomedicsFMS-368HJ2024-09-03
00031262113740HomedicsFMS-401HJ-1PK2024-09-03
00031262113719HomedicsFMS-353HJ2024-08-30
00031262115218HomedicsMCS-116HJA2024-08-30
00031262115744HomedicsHHP-231J-GY2024-08-20
00031262112323HomedicsMCS-112HJ2024-08-15
00031262112859HomedicsSP-92HJ2024-08-15
00031262115430HomedicsFB-50J-BK2024-08-15
00031262114365HomedicsFB-50J-GY2024-07-30
00031262113702HomedicsFMS-347HJ2024-07-25
00031262112484HomedicsFB-50J-NV2024-07-15
00031262112491HomedicsFB-52J-LL2024-07-15
00031262112170HomedicsFMS-405HJAMZ-RM2024-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018480888Primo PassiPrimo Passi LLCISA2026-09-21
00860014139918QUASONIQ+Global Good, Corp.ISA2026-09-21
06977444420005Shuhai JingweiShuhai Jingwei (Shenzhen) Information Technology Co., Ltd.ISA2026-09-04
08800250281332QuadtheraECO DM LAB Co., Ltd.ISA2026-08-21
00817915020296Etekcity Smart Fitness ScaleVesync (US) CorporationISA2026-08-14
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