CORFLEX

FDA Device Registration & Listing · MANCHESTER, NH, US · Registration 1218997

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1218997
FEI Number
1218997
Entity Name
CORFLEX
City/State/Country
MANCHESTER, NH, US
Establishment Address
669 EAST INDUSTRIAL PARK, DRIVE, MANCHESTER, NH 03109, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Corflex Global, LLC (Owner Number: 1218997)
Owner / Operator Contact Address
669 EAST INDUSTRIAL, PARK DRIVE, Manchester, NH 03109, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

DISC UNLOADER SPINAL ORTHOSIS L VQ LSO ASCENT AP LG/XL BODY/ LATERALS VQ TRUVERSE PANEL HOOD & COVER FABRIC ONLY REALIGN EXTENSION KIT 16" CITRUS SPINE INSTITUTE LACE ALIGN LO PANEL HOOD VQ LSO ASCENT LO PANEL COVER W/PLASTIC OSS REALIGN LSO PANEL HOOD FABRIC ONLY VQ LSO ASCENT AP+ SM/MD (510020-SM) ONC LACE ALIGN LSO PANEL HOOD DISC UNLOADER SPINAL ORTHOSIS M 15" EXTENSION KIT LACER BACK ORTHOSIS VQ LSO ECLIPSE APL LG/XL (510030-LX) REALIGN SPINAL ORTHOSIS LSO UNIV SPINE & PAIN INSTITUTE FL LACE ALIGN LSO PANEL HOOD PATRIOT BACK BRACE FLORIDA SPINE ASSOCIATES LACE ALIGN LSO PLUS PANEL HOOD IVY SPINE ORTHOPEDICS TLSO PANEL COVER LACE ALIGN TLSO COVER KIT LACE ALIGN GEL POUCH LACE ALIGN LSO SIDE PANELS REALIGN SPINAL ORTHOSIS LO UNIV DISC UNLOADER 6" FRONT PANEL ONLY S/M RESURGENS LACE ALIGN LO PANEL COVER LACE ALIGN SPINAL ORTHOSIS LO S/M EMBROIDERY HEALTH FIRST LOGO LSO PANEL (CNTR, 2.5" FRM BTTM) THE SHOULDER CLINIC RANGER CUFF LDPE MID LENGTH INSERT 3.5" x 4.75" VQ LSO ASCENT AP+ LG/XL (510020-LX) REALIGN LSO PANEL COVER ONLY SC PAIN & SPINE SPECIALISTS LACE ALIGN LSO PANEL HOOD LACE ALIGN PATTERN TACK (LACER GUIDES, ZZ) LACE ALIGN NYLON TLSO DIE CUT PANEL EMBROIDERY TNC PAIN MANAGEMENT LOGO TLSO PANEL RALEIGH ORTHOPAEDIC RANGER CUFF LACE ALIGN SPINAL ORTHOSIS LSO PLUS L/XL E/N LUMBAR SUPPORT BLACK 3XL ORTHOGEORGIA LACE ALIGN LO PANEL COVER REALIGN LSO HOOD OSS LOGO REGIONAL MEDICAL PATRIOT BACK COVER VQ LSO ECLIPSE AP SM/MD (510010-SM) MSA ORTHOPEDIC LACE ALIGN LO PANEL HOOD VQ TRUVERSE LSO PANEL COVER ONLY LUMBAR STRAP PINEHURST SURGICAL LACE ALIGN LSO PANEL HOOD REALIGN LO PANEL COVER ONLY CELEBRATION ORTHOPAEDIC HOOD PANEL TNC PAIN MANAGEMENT LACE ALIGN TLSO PANEL HOOD REALIGN LO BACK PANEL REALIGN SPINAL ORTHOSIS LSO PLUS UNIV VQ LSO ASCENT LSO PANEL HOOD DISC UNLOADER SPINAL ORTHOSIS S COMPREHENSIVE SPINE LACE ALIGN LSO PANEL HOOD LACE ALIGN SPINAL ORTHOSIS LSO L/XL INTERVENTIONAL PAIN & SPINE LACE ALIGN LSO PANEL HOOD IVY SPINE ORTHOPEDICS LSO PANEL HOOD CITRUS SPINE INSTITUTE LACE ALIGN LSO PANEL HOOD CORFLEX LACE ALIGN LSO PANEL HOOD & COVER FABRIC ONLY VQ LSO ECLIPSE PANEL HOOD & COVER FABRIC ONLY LACE ALIGN SPINAL ORTHOSIS LSO PANEL COVER W/PLASTIC CORFLEX LACE ALIGN LSO PANEL HOOD E/N LUMBAR SUPPORT BLACK XS ADVANCE PAIN LACE ALIGN LO PANEL COVER LACE ALIGN SPINAL ORTHOSIS LO L/XL 3/8" BLACK FOAM PAD W/1" HOOK TAB VQ LSO ASCENT AP SM/MD BODY/LATERALS VQ LSO ECLIPSE AP LG/XL (510010-LX) VQ TRUVERSE AP+ SPINE LSO UNIV (510070) LACE ALIGN SPINAL ORTHOSIS TLSO UNIV ORTHOPAEDIC ASSOCIATES LO PANEL HOOD LACER BACK GENERIC PULL TAB W/EYELET ORTHOPAEDIC ASSOCIATES TLSO PANEL HOOD FLORIDA PAIN MANAGEMENT LACE ALIGN LSO PANEL HOOD E/N LUMBAR SUPPORT BLACK XL REALIGN LSO BACK PANEL REGIONAL MEDICAL PATRIOT II BACK BRACE UNIVERSAL REALIGN LSO HOOD NO LOGO GEORGIA O&P LACE ALIGN LO PANEL COVER E/N LUMBAR SUPPORT BLACK 2XL CORFLEX LACE ALIGN TLSO PANEL COVER THE BACK CENTER LACE ALIGN LSO PLUS PANEL HOOD 16" LACE ALIGN EXTENSION KIT VQ TRUVERSE APL SPINE LSO PLUS UNIV (510080) LACE ALIGN WING SET LARGE LDPE EXT LENGTH INSERT 3.5" x 6.75" CORFLEX RANGER SHOULDER STRAP ALASKA ORTHOPEDIC SPECIALISTS RANGER CUFF VQ LSO ASCENT AP SM/MD (510010-SM) VQ TRUVERSE PANEL HOOD FABRIC ONLY REALIGN WING SET UNIV GEORGIA O&P LACE ALIGN LSO PANEL HOOD LSO BACK PANEL W/ FOAM DISC UNLOADER SPINAL ORTHOSIS 2XL CORFLEX LACE ALIGN LO PANEL COVER FABRIC ONLY ADVANCE PAIN LACE ALIGN LSO PANEL HOOD OSS REALIGN PANEL HOOD & COVER FABRIC ONLY DISC UNLOADER SPINAL ORTHOSIS XL VQ LSO ASCENT AP LG/XL (510010-LX) LACE ALIGN HDPE ANTERIOR PANEL E/N LUMBAR SUPPORT BLACK M LACE ALIGN SPINAL ORTHOSIS BODY/LATERALS S/M VQ LO ECLIPSE LO PANEL COVER FABRIC ONLY DIE OUTLAST LACE ALIGN EXTENSION PANEL VQ LSO ASCENT APL LG/XL (510030-LX) MSA ORTHOPEDIC LACE ALIGN LSO PANEL HOOD ORTHOPAEDIC ASSOCIATES LSO PANEL HOOD DISC UNLOADER SPINAL ORTHOSIS 4XL E/N LUMBAR SUPPORT BLACK 4XL VQ LSO ECLIPSE TLSO UNIV (510050) EMBROIDERY TNC PAIN MANAGEMENT LOGO LSO PANEL DISC UNLOADER 6" FRONT PANEL ONLY XS LACE ALIGN SPINAL ORTHOSIS LO PANEL E/N LUMBAR SUPPORT BLACK S DISC UNLOADER SPINAL ORTHOSIS XS SPINE INST CENTRAL FL LACE ALIGN LSO PANEL HOOD ORTHOGEORGIA RANGER CUFF BIOSPINE LACE ALIGN LSO PANEL HOOD CORFLEX LACE ALIGN LSO PANEL COVER FABRIC ONLY HEROLD'S NORTH PHARM LACE ALIGN LSO PANEL HOOD LACE ALIGN LSO SIDE PANELS COVER W/PLASTIC PALM TREE LACE ALIGN LSO PANEL HOOD RESURGENS LACE ALIGN LSO PANEL HOOD LACE ALIGN SPINAL ORTHOSIS LSO PANEL TRUVERSE EXTENSION KIT 16" (510090) CORFLEX RANGER CUFF VQ LSO ECLIPSE APL SM/MD (510030-SM) LACE ALIGN SPINAL ORTHOSIS LO PANEL COVER W/PLASTIC LACE ALIGN NYLON LSO DIE CUT PANEL EXPERT PAIN LACE ALIGN LSO PANEL HOOD VQ LSO ECLIPSE AP+ LG/XL (510020-LX) LACE ALIGN SPINAL ORTHOSIS LSO PLUS S/M REALIGN LO PANEL HOOD FABRIC ONLY REALIGN LO COVER NO LOGO REALIGN LSO SIDE PANELS DISC UNLOADER SPINAL ORTHOSIS 3XL LACE ALIGN SPINAL ORTHOSIS LSO S/M LACE ALIGN NYLON LO DIE CUT PANEL REALIGN LSO PANEL HOOD FABRIC ONLY LACE ALIGN LSO COVER KIT VQ TRUVERSE AP SPINE LO UNIV (510060) VQ LSO ASCENT APL SM/MD (510030-SM) DISC UNLOADER 6" FRONT PANEL ONLY LG/XL REGIONAL MEDICAL PATRIOT BACK COVER SUBASSY VQ LSO ECLIPSE AP+ SM/MD (510020-SM) REALIGN LSO PANEL HOOD & COVER FABRIC ONLY HEALTH FIRST LACE ALIGN LSO PLUS PANEL HOOD LACE ALIGN LO COVER KIT TNC PAIN MANAGEMENT LACE ALIGN LSO PANEL HOOD LACE ALIGN SPINAL ORTHOSIS BODY/ LATERALS L/XL VQ LSO ASCENT LSO PANEL COVER W/PLASTIC E/N LUMBAR SUPPORT BLACK L ORTHOGEORGIA LACE ALIGN LSO PANEL HOOD ALASKA HES RANGER CUFF CKI / WHEATON STRAP 10" CKI / WHEATON STRAP 8" CKI/ WHEATON STRAP 12" CKI STRAP 10" CKI STRAP 12" UNIVERSAL COMFORT SHOULDER IMMOBILIZER ULTRA SHOULDER IMMOBILIZER W/PAD M ULTRA ARM SLING W/PAD XS BLACK TRICOT ARM SLING M BLACK TRICOT SHOULDER IMMOBILIZER XL 1.5" X 2" LOW PROFILE HOOK TAB W DEADENED TIP ULTRA SHOULDER ABDUCTION PILLOW W/SLING L BLACK ELASTIC W/1" HOOK 1.5 X 6.5" STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 18" ULTRA ARM SLING W/PAD XL HOOK 65 TONGUE BLACK 1.5" X 2.5" RANGER SLING STRAP KIT ULTRA SHOULDER IMMOBILIZER W/PAD XL BLACK TRICOT ARM SLING XS STRAP WHITE #255708 1 X 8.5" STRAP BLK 2 X 22" (NO LOOP LOC) FACE STRAP WHITE 1.5 X 7" (9.5" overall length) ULTRA SHOULDER IMMOBILIZER XS BLACK TRICOT ARM SLING L ECONOMIZER ARM SLING S DALC 9" COOLTEX WRIST SPLINT W/ STRAP IFU ECONOMIZER SHOULDER IMMOBILIZER M SHOULDER ABD PILLOW W/FIRM FIT SLING L ECONOMIZER ARM SLING XL BLACK TRICOT SHOULDER IMMOBILIZER L ULTRA SHOULDER IMMOBILIZER W/PAD L RANGER GS SHOULDER ABDUCTION BRACE WHEATON STRAP 12" RANGER II COMFORT HARNESS W/PADS RANGER GS FRAME COVER W/PADDED WAISTBAND CONTENDER POST-OP ELBOW REPLACEMENT SLING UNIV RANGER SHOULDER IMMOBILIZER STRAP WHITE #255701 2 X 15" BLACK TRICOT ARM SLING S WHEATON STRAP 08" BLACK FACE STRAP (CON. TENNIS ELBOW STRAP) 1.5 X 8" RANGER II SHOULDER ABDUCTION PILLOW W/SLING ELASTIC SHOULDER IMMOBILIZER S FIRM FIT SHOULDER ABDUCTION PILLOW SPACER MESH BLACK 100 58" WIDTH ECONOMIZER SHOULDER IMMOBILIZER XL STRAP BLACK 1"X8.5" RANGER PILLOW ULTRA SHOULDER IMMOBILIZER XL STRAP ELASTIC BLACK 3"X12" ULTRA SHOULDER ABD PILLOW SM/MED STRAP ELASTIC BLACK 3"X8" TEMP MATERIAL SUBSTITUTION NOTE 2.125" X 5.5" ELASTIC SHOULDER IMMOBILIZER XL ACETAL D-RING BLACK 1.5" FACE STRAP WHITE 1.5 X 9" (11.5" overall length) RANGER SHOULDER SLING BODY ULTRA ARM SLING 2XL ULTRA ARM SLING S 3" x 14.5" PERF ELASTIC STRAP MD-L ULTRA SHOULDER IMMOBILIZER M ECONOMIZER ARM SLING XS ELASTIC SHOULDER IMMOBILIZER XS PADDED STRAP SLING XL STRAP BLK 2 X 15" (NO LOOP LOC) RANGER AP FRAME PAD FACE STRAP BLACK 1.5 X 8" (10.5" overall) 61MM BLK POLYURENTHANE BALL W/LOGO STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 20" STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 24" RANGER SHOULDER SLING PADDED STRAP SLING XS PALMAR STAY 2 BEND 1" X 6.75" FACE STRAP WHITE 1.5 X 10.5" (12.5" overall length) SLING PADDED STRAP BLUE FOAM W/HOOK 40" PADDED STRAP SHOULDER IMMOBILIZER XL ULTRA ARM SLING W/PAD M 3" x 12.5" PERF ELASTIC STRAP XS-SM STRAP POLYCAST WHITE 1 X 9" STRAP ANGLE CUT BLACK 1"X9" BLACK ELASTIC W/1" HOOK 1.5 X 5.5" CORFLEX LACE ALIGN TLSO PANEL HOOD & COVER FABRIC ONLY ECONOMIZER SHOULDER IMMOBILIZER S SHOULDER ABD PILLOW W/FIRM FIT SLING M ULTRA ARM SLING XS ELASTIC SHOULDER IMMOBILIZER L STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 14" ULTRA SHOULDER IMMOBILIZER W/PAD S STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 28" ECONOMIZER ARM SLING 2XS STRAP WHITE #255706 2 X 22" (25" overall) RANGER SLING CUFF DIE CUT BODY STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 22" STRAP W/LOOP-LOC & VEL-LOOP 1"X16" WHEATON STRAP 10" BLACK TRICOT SHOULDER IMMOBILIZER M 3" x 16.5" PERF ELASTIC STRAP 3XL ELASTIC SHOULDER IMMOBILIZER 2XL SHOULDER ABD PILLOW BALL HOLDER W/BALL FACE STRAP BLACK 1.5"X10" HOOK TONGUE BLACK 2 X 3" PADDED STRAP SHOULDER IMMOBILIZER XS BLACK TRICOT ARM SLING XL ULTRA SHOULDER IMMOBILIZER S STRAP BLACK 2 X 18" STRAP BLACK 2 X 26" HOOK 88 TONGUE BLACK 1.5" X 2.5" STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 16" WAIST PADDED STRAP BLUE FOAM W/HOOKS 33" STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 34" HOOK ALLIGATOR TAB W/KNIT LOOP 1" X 1.25" STRAP W/LOOP-LOC & VEL-LOOP 1"X27" STRAIGHT STAY 1/2" X 6" LOOP 1.5"X1" WITH 1.5" LOOP LOC - BLACK STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 30" 3MM AIRMESH NS BLK 59/60" STRAP W/LOOP-LOC & VEL-LOOP 1"X29" ECONOMIZER SHOULDER IMMOBILIZER L STRAP ELASTIC BLACK 3"X10" SUPPLY CHAIN MISC ORDERS BLACK MOLDED HOOK TAB W/KNIT LOOP 1.25"x2.5" STRAP W/LOOP-LOC & VEL-LOOP 1"X23" PADDED STRAP SLING UNIVERSAL RANGER GS SPLINT FRAME W/COVER BLACK ELASTIC W/1" HOOK 1.5 X 5" ULTRA SHOULDER IMMOBILIZER L FACE STRAP BLACK 1.5 X 9" (11.5" overall) ULTRA SHOULDER ABDUCTION PILLOW W/SLING M PADDED STRAP SHOULDER IMMOBILIZER UNIVERSAL ELASTIC SHOULDER IMMOBILIZER 3XL ULTRA ARM SLING M STRAP BLACK 2"X14.5" STRAP BLACK 2 X 34" STRAP W/LOOP-LOC & VEL-LOOP 1"X18" RANGER UNIVERSAL SLING LDPE 1/8" X 24" X 24" WHITE STRAP BLACK 2 X 28" ULTRA ARM SLING L RANGER SHOULDER ABDUCTION PILLOW WITH SLING ULTRA ARM SLING XL RANGER GS SHOULDER ABD BRACE IFU (23-2360) 8" COOLTEX THUMB SPICA W/ STRAP IFU STRAP ANGLE CUT BLACK 1.5"X10" LOOP 1"X1" WITH 1" LOOP LOC - BLACK 2" X 2" LOW PROFILE HOOK TAB W DEADENED TIP ULTRA ARM SLING W/PAD S COLLAR & CUFF SLING STRAP BLACK 2 X 22" ULTRA SHOULDER IMMOBILIZER 2XS ULTRA SHOULDER IMMOBILIZER W/PAD XS FACE STRAP WHITE 1.5 X 8"  (10.5" overall length) BLACK TRICOT SHOULDER IMMOBILIZER XS POEB HOOK BLACK METAL CUFF 3" X 1.5" SHOULDER ABD PILLOW W/FIRM FIT SLING XL ELASTIC SHOULDER IMMOBILIZER M HOOK BEL-TIP W/KNIT LOOP BLACK 2 X 2" ULTRA ARM SLING W/PAD L ER SHOULDER WEDGE AND STRAP 3" x 15.5" PERF ELASTIC STRAP XL-2XL RANGER II GS SHOULDER ABD BRACE IFU (23-2560) EZ TAB BLACK 2 X 4" ULTRA SHOULDER ABDUCTION PILLOW W/SLING S STRAP WHITE 2" X 12 1/2" STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 36" UNIVERSAL SLING & SWATHE SHOULDER ABD PILLOW W/FIRM FIT SLING S BLACK FACE STRAP (CON. TENNIS ELBOW STRAP) 1.5 X 5.5" STRAP BLK 2 X 24" STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 32" ECONOMIZER ARM SLING L BLACK ALLIGATOR TAB W/KNIT LOOP 1.25"x3" EXTENDED + MID LENGTH HUMERAL STRAP STRAP BLACK 2 X 20" ULTRA SHOULDER ABDUCTION PILLOW W/SLING XL STRAP W/ VELSTRETCH AND LOOP LOC BLACK 2 X 26" ULTRA SHOULDER ABD PILLOW LG/ X-LG PALMAR STAY 2 BEND 1" X 7.5" STRAP W/LOOP-LOC & VEL-LOOP 1"X25" RANGER SLING AND SHOULDER IMM IFU (21-1960/23-1960) LEO G. STEIN LOOP DOUBLE FACED (3610) BLK 1.5" ECONOMIZER ARM SLING M STRAP W/LOOP-LOC & VEL-LOOP 1"X21" BLACK TRICOT SHOULDER IMMOBILIZER S STRAP BLACK 2 X 30"

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IQE Orthosis, Lumbar Physical Medicine Class 1 890.3490 2013-12-16
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2013-12-16
ILI Sling, Arm Physical Medicine Class 1 890.3640 2001-10-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Corflex Global, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1218997. Last updated year: 2026. Please use registration number 1218997 when referencing this establishment in official correspondence.
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