FDA.reportPublic FDA data

Air Flex with Auto-Distraction

Primary DI
00860001452525
Brand
Air Flex with Auto-Distraction
Company
HILL LABORATORIES CO.
Model
Air Flex II with Auto-Distraction
Published
2020-02-04
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
JFBTable, Physical Therapy, Multi Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFBTable, Physical Therapy, Multi FunctionPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063034000AIR-FLEX WITH AUTO-DISTRACTIONHill Laboratories Co.2006-12-14JFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001452525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001452525008600014525258600014525250860001452525

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
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
08800091150620N motionNuga Medical Co.,Ltd.JFB2025-12-19
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.JFB2025-07-15
08809494000686CERAGEM Master V7CERAGEM Co., Ltd.JFB2025-02-12
08809494000983CERAGEM Master V7CERAGEM Co., Ltd.JFB2025-02-12
08809643652476CERAGEM Master V5CERAGEM Co., Ltd.JFB2025-02-12
08800091150132NUGABESTNuga Medical Co.,Ltd.JFB2022-09-28
08809494000082CERAGEM Master V6CERAGEM Co., Ltd.JFB2021-03-31
08809494000099CERAGEM Master V6CERAGEM Co., Ltd.JFB2021-03-31
08809494000075CERAGEM Master V4CERAGEM Co., Ltd.JFB2021-03-12
B556HY7000U0MigunMIGUN LIFE CO., LTDJFB2017-05-01
B556HY7000UM0MigunMIGUN LIFE CO., LTDJFB2017-05-01
B344HY7000U0MigunMIGUN LIFE INCJFB2017-02-11
B344HY7000UM0MigunMIGUN LIFE INCJFB2016-09-19
08809494000006CERAGEM Master V3CERAGEM Co., Ltd.JFB2016-07-29