FDA.reportPublic FDA data

Air Flex II

Primary DI
00860001452570
Brand
Air Flex II
Company
HILL LABORATORIES CO.
Model
Air Flex II
Published
2023-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HSTApparatus, Traction, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSTApparatus, Traction, Non-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001452570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001452570008600014525708600014525700860001452570

GMDN Terms#

Term, Definition table
TermDefinition
Body arch traction tableA fixed framework table designed to support the body of a patient and provide traction for the back muscles and spine by flexing the patient into a reverse supine body arch. The patient locks their feet behind a cross-member and bends backward over the curvature of the table to flex the vertebrae of the spine, relieving spinal compression, relaxing the shoulders, neck, and back muscles, whilst stretching and strengthening the core muscles of the body. This device can be used in a healthcare facility or in the home to assist patients eliminate/alleviate back pain.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002326585
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850058158051HA90PHA90P2023-10-24
00850058158075HA90PTHA90PT2023-10-24
00850058158105HI-LOHI-LO2023-10-24
00850058158136Rath Mechanical Extension TableRath Mechanical2023-10-24
00860001452556Spinalight, IncSpinalight C-10002023-10-24
00850058158037HA90LBC CounterstrainHA90LBC Counterstrain2023-10-23
00860001452587HA90CHA90C2023-10-23
00860001452594HA90HA902023-10-23
00860011173601HA90EHA90E2023-10-23
00860001452532HF54, HorizonHF54, Horizon2020-02-04
00850058158143The SAVE ProgramSAVE Motion Chair2024-03-11
00860011173649Advanced Chiropractic Equipment LLCHA90RD2023-10-23
00850058158006HA90RHA90R2023-10-24
00850058158068HA90PHHA90PH2023-10-24
00850058158082HA90VHA90V2023-10-24
00850058158099HA90WHA90W2023-10-24
00850058158112Massage TableMassage Table2023-10-24
00850058158129PT Tilt TablePT Tilt Table2023-10-24
00850058158013HA90DHA90D2023-10-23
00850058158020HA90LBHA90LB2023-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776415174MillenniumAvalign Technologies, Inc.HST2025-12-03
00842430116728TRAPEZE ARM ASSEMBLY, PATIENT HELPERMIZUHO ORTHOPEDIC SYSTEMS, INC.HST2025-07-28
00887482122723Symmetry LoganASPEN SURGICAL PRODUCTS, INC.HST2024-08-20
00615521004712ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004736ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004750ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004828ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004842ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00840277130495Innomed, Inc.INNOMED, INC.HST2024-05-09
00860011457800IHNIHN, Inc.HST2024-02-07
00860011457817IHNIHN, Inc.HST2024-02-07
10860011457807IHNIHN, Inc.HST2024-02-07
10860011457814IHNIHN, Inc.HST2024-02-07
00840277129444Innomed,Inc.INNOMED, INC.HST2023-12-19
00840277129451Innomed, Inc.INNOMED, INC.HST2023-12-19
00840277129468Innomed,Inc.INNOMED, INC.HST2023-12-19
00840277129475Innomed, Inc.INNOMED, INC.HST2023-12-19
00840277129482Innomed, Inc.INNOMED, INC.HST2023-12-19
00840277129499Innomed, Inc.INNOMED, INC.HST2023-12-19
00724995225544NASTERIS CORPORATIONHST2023-11-17
00860011173618AFTHILL LABORATORIES CO.HST2023-10-23
00860011173625Air Drop AFTHILL LABORATORIES CO.HST2023-10-23
04719871180167EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HST2023-08-24
04719871180365EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HST2023-08-24
00615521001490ALLENHILL-ROM, INC.HST2023-07-31
00615521001506ALLENHILL-ROM, INC.HST2023-07-31
00615521012823ALLENHILL-ROM, INC.HST2023-07-31
00615521021160ALLENHILL-ROM, INC.HST2023-07-31
00615521021177ALLENHILL-ROM, INC.HST2023-07-31
00615521021184ALLENHILL-ROM, INC.HST2023-07-31