FDA.reportPublic FDA data

BIOS Living

Primary DI
10057475570443
Brand
BIOS Living
Company
Thermor Ltd
Model
57044
Device description
Thera Ball - Natural Heat
Published
2023-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IMAPack, Heat, Moist

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMAPack, Heat, MoistPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10057475570443PackageGS112In Commercial Distribution
00057475570446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747557044310057475570443
00057475570446000574755704460574755704460057475570446

GMDN Terms#

Term, Definition table
TermDefinition
Moist-heat packA device intended to be applied with pressure to the body surface to provide moist heat therapy to reduce muscle spasms and cramps and/or joint and muscle stiffness and pain. It usually consists of a soft pad or a small pouch made of cotton, gauze, or linen available in a variety of thickness; it may also contain gel or absorbent materials. The device can be warmed in hot water or in a microwave oven. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
246883458
Device count
1
DM exempt
false
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
00057475032500BIOS DiagnosticsW2502026-01-19
00057475491505BIOS DiagnosticsNS1502026-01-19
20057475032504BIOS DiagnosticsW2502026-01-19
00057475242909BIOS DiagnosticsBD2902026-01-19
10057475491502BIOS DiagnosticsNS1502026-01-19
00057475820213BIOS LivingRL0212026-01-19
00057475220495BIOS Diagnostics220DI2023-09-20
00057475282493BIOS282DI2023-05-23
00057475282738BIOS LivingLH2732024-03-21
00057475282745BIOS LivingLH2742024-03-21
00057475561017BIOS LivingEP1012024-03-22
00057475561024BIOS LivingEP1022024-03-22
00057475561031BIOS LivingEP1032024-03-23
00057475561048BIOS LivingEP1042024-03-23
00057475561055BIOS LivingEP1052024-03-22
00057475561062BIOS LivingEP1062024-03-22
00057475561079BIOS LivingEP1072024-03-22
00057475561086BIOS LivingEP1082024-03-22
00057475561093BIOS LivingEP1092024-03-22
00057475561222BIOS LivingEP1222024-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04979844700116NEW MOXA STICKYAMASHO CO.,LTD.IMA2025-02-03
04979844930506MOGUSAN'S MOXA BOXYAMASHO CO.,LTD.IMA2025-02-03
04979844931008DEDICATED CARBONIZED MOXAYAMASHO CO.,LTD.IMA2025-02-03
04979844580015NON-SMOKE CHOSEI-KYU MOXAYAMASHO CO.,LTD.IMA2024-06-17
04979844580039NON-SMOKE CHOSEI-KYU MOXAYAMASHO CO.,LTD.IMA2024-06-17
16901452000178Hwato Stick-on MoxaSuzhou Medical Appliance FactoryIMA2023-11-15
06901452000171Hwato Stick-on MoxaSuzhou Medical Appliance FactoryIMA2023-11-15
14897076722454Tiger.Warm.STENS PLUS INDUSTRIAL COMPANYIMA2023-06-05
14897076722546Tiger.Warm.STENS PLUS INDUSTRIAL COMPANYIMA2023-06-05
06971175122368sunwin momShanghai Senwo Industry Co., Ltd.IMA2023-05-13
14897076721778Roll.Smoke.LSuzhou Shenlong Medical Apparatus Co., Ltd.IMA2023-04-07
00057475570446BIOS LivingThermor LtdIMA2023-03-31
08800018916537Smokeless Mini MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
08800018916544GuGwan Moxa SmokelessDong Bang Medical co.,Ltd.IMA2023-01-15
08800018916551GuGwan MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
08800018916568Gold MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
18800018914561DBC Moxa BurnerDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916411Tiger Warmer SmallDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916428Tiger Warmer LargeDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916435CHARCOAL SMOKELESS MOXA CONESDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916442GuGwan Burning Bowl 1HoleDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916459GuGwan Burning Bowl 5HolesDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916510"""Moxa Shield """Dong Bang Medical co.,Ltd.IMA2023-01-15
18800018916534Smokeless Mini MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916541GuGwan Moxa SmokelessDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916558GuGwan MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916565Gold MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
28800018916432CHARCOAL SMOKELESS MOXA CONESDong Bang Medical co.,Ltd.IMA2023-01-15
06971175125567sunwin momShanghai Senwo Industry Co., Ltd.IMA2022-12-30
00810084936887FifthPulseJeg & Sons Inc.IMA2022-12-16