Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005621376

FEI Number

3005621376

Entity Name

POLYGEL LLC.

City/State/Country

Palmer TWP, PA, US

Establishment Address

1 Danforth Drive, Palmer TWP, PA 18045, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

POLYGEL LLC. (Owner Number: 9080190)

Owner / Operator Contact Address

1 Danforth Dr., --, Palmer, PA 18045, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MGEL MESH DIGITAL TOE/FINGER CAP GELSMART GEL TUBING NARROW (EACH) RIBBED 20MM MGEL DIGITAL PAD - 609 MM (24") MGEL FULLY COATED DIGITAL MESH TUBE - 152MM (6") MGEL HALF COATED DIGITAL STRIP - 609MM (24") MGEL TRADITIONAL DIGITAL CAPS MGEL CORN PAD MGEL FULLY COATED DIGITAL TUBE - 152 MM (6") MGEL SEAMLESS TIP DIGITAL CAP MGEL MESH SLEEVE - 254MM (10') MGEL FULLY COATED MESH SLEEVE GELSMART GEL TUBING WIDE (EACH) RIBBED 25MM MGEL DIGITAL PAD ON A STRIP NATRACURE ARTHRITIS COMPRESSION GLOVES (615-02 CAT/615-03 CAT/615-04 CAT) NATRACURE PLANTAR FASCITIS NIGHT SPLINT (W/GEL THERMOACTIVE BACK SUPPORT WITH SUPPORTS (LSO) NATRACURE NEOPRENE MAGNETIC SHOULDER SUPPORT THERMOACTIVE ELBOW ORTHOSIS SUPPORT WITH POLYCENTRIC HINGES THERMOACTIVE KNEE ORTHOSIS WITH ROM HINGES NIGHT-TIME BUNION SPLINT THERMOACTIVE ELBOW ORTHOSIS SUPPORT WITH ROM HINGES THERMOACTIVE WRIST SYSTEM ORHTOSIS WITH SPLINT NATRACURE KNEE COMPRESSION SLEEVE, SINGLE WRAP (605-02 CAT/605-03 CAT/605-04 CAT/605-05 CAT/ THERMOACTIVE KNEE ORTHOSIS WITH POLYCENTRIC HINGES THERMOACTIVE MEDICAL SHOULDER ORTHOSIS THERMOACTIVE MEDICAL HIP ORTHOSIS SGEL BAMBOO KNEE SLEEVE FLEXIKOLD NECK COLD PACK THERMOACTIVE KNEE NATRACURE UNIVERSAL WRAP W/BEADS NATRACURE HOT/COLD FOOT & ARCH RELIEF (BLACK) THEROMACTIVE SHOULDER LEFT/RIGHT 4" Circle Cold Pack - 2 PK NATRACURE COLD THERAPY BOOTIES SB EXTREME MOISTURE SHOULDER THERMOACTIVE LARGE KNEE COLD SLEEVE NATRACURE HEAT THERAPY BOOTIES THERMOACTIVE ANKLE GEL PACK THERMOACTIVE THIGH NATRACURE HEAT THERAPY MITTENS THERMOACTIVE ARM/CALF THERMOACTIVE THIGH GEL PACK NATRACURE HOT/COLD FASCIA RELIEF SOCK THERMOACTIVE WRIST GEL PACK COMPRESSION FOOT SLEEVES COMPRESSION KNEE SLEEVE THERMOACTIVE BACK NATRACURE ARCH HOT/COLD WRAP (350x90mm) PF COMPRESSION ARCH SLEEVE COMPRESSION HEEL SLEEVE FLEXIKOLD OVERSIZE COLD PACK THERMOACTIVE KNEE GELPACK NATRACURE HOT/COLD 5-MINUTE ARCH FIXER THERMOACTIVE ARM/CALF GEL PACK THERMOACTIVE WRIST FLEXIKOLD HALF SIZE COLD PACK THERMOACTIVE ELBOW GEL PACK 4" CIRCLE GEL COLD PACK NATRACURE COLD THERAPY SOCKS THERMOACTIVE ANKLE THERMOACTIVE SHOULDER GEL PACK LEFT/RIGHT FLEXIKOLD STANDARD COLD PACK THERMOACTIVE LARGE ANKLE MAGNETIC SHOULDER SUPPORT THERMOACTIVE LARGE ANKLE GEL PACK DRY EYE MOISTURE H/C MASK - SILICA BEADS THERMOACTIVE ELBOW DRY EYE MOISTURE H/C MASK THERMOACTIVE BACK GEL PACK NATRACURE WARMING SHOULDER & BODY WRAP NATRACURE NECK WRAP W/BEADS NATRACURE UNIVERSAL COLD PACK ICE WRAP NATRACURE SHOULDER & BODY WRAP W/BEADS NATRACURE HOT/COLD FOOT & ARCH RELIEF (BLUE) THERMOACTIVE LARGE KNEE GELPACK CHEMO COLD CAP CHEMO COLD SLIPPERS CHEMO COLD MITTS BLUEPOINT HEEL WEDGE W SOFT CENTRE SIZE 2-5 BLUEPOINT LOW PROFILE HEEL WAFFLE SIZE 9+ MGEL ACHILLES HEEL PROTECTION SLEEVE MGEL ROLLED DIGITAL PAD UGEL CALLUS PAD NEVER SLIP UNIVERSAL TOE CRESTS ALL GEL TOE PROTECTOR M2 GEL ALL GEL ADVANCED TOE SPREADER MGEL ANKLE PROTECTION SLEEVE NATRACURE VENTED MOISTURIZING GEL HEEL SLEEVE SILICONE HEEL CUP (PROCARE) UGEL FLEXIBLE BALL OF FOOT CUSHION NEVER SLIP BLUEPOINT 3/4LENGTH GEL INSOLES SIZE 9+ UGEL FLEXIBLE 3/4 LENGTH DRESS INSOLE NEVER SLIP DD SPUR CUP-LG MED/SOFT DURO GELSMART M-GEL EXERFEET TOE STRETCHER SINGLE L/XL NATRACURE DOUBLE BUNION W/METATARSAL GEL PAD PINK MICROFIBER BOOTIES SGEL MEDIUM RECOVERY WEDGE CENTER SOFT SPOT BLUEPOINT HIGH HEEL W MET RISE SIZE 6-8 CTZ TOE CREST - RIGHT DROP SHIP - BLUEPOINT GEL HEEL CUPS SIZE 2-5 GEL SANDAL SPREADER W/BALL OF FOOT CUHION (sandal spreader) MGEL DOT WITH PRESSURE SENSITIVE ADHESIVE NATRACURE ARCH FIXER (L/XLG) SGEL LOW PROFILE HEEL WEDGE SOFT SPUR SPOT AQUA GEL HEEL SLEEVES (Natracure only) BLUEPOINT HEEL WEDGE W SOFT SPUR SIZE 9+ DD SPUR CUP-XXL SOFT DURO M2GEL ALL GEL FIFTH DIGIT CORN PAD MGEL COMFORT GEL SKIN BUNION RELIEF SLEEVE - EXTRA PROTECTION UGEL FLEXIBLE SELF ADHESIVE HEEL GRIP BLUEPOINT FULL LENGTH GEL INSOLES SIZE 4-5 BUNION RELIEF W/APER CUSH FLEXIBLE SELF ADH. HEEL GRIP MICROFIBER GEL BOOTIES NATRACURE GEL METATARSAL WRAP (SM/MED) BLUEPOINT HIGH HEEL W MET PAD SIZE 6-8 PAIR DOUBLE LOOP BUNION SPREADER MGEL COMFORT GEL SKIN DOUBLE BUNION MET SLEEVE UGEL SANDAL SPREADER BLUEPOINT HIGH HEEL W MET PAD SIZE 9+ PAIR DOUBLE LOOP TAILOR BUNION SPDR MGEL COMFORT GELSKIN FOREFOOT CUSHION WITH STRAP MOISTURIZING VENTED HEEL SLEEVE UGEL THONG PROTECTOR WITH MET PAD BLUEPOINT HIGH HEEL W MET RISE SIZE 2-5 CTZ TOE CREST - LEFT DRESS BUNION RELIEF PAD MGEL DORSUM PROTECTION SLEEVE NATRACURE 5-TOE MOISTURIZING GEL SOCKS SGEL LOW PROFILE HEEL - WAFFLE DESIGN UNIVERAL COLD WRAP BLUEPOINT 3/4LENGTH GEL INSOLES SIZE 6-8 TGEL DUAL DENSITY INSOLE WITH TOP COVER DBL BUNION MET SLEEVE-S/M CGS DUAL DENSITY HEEL CUP GEL TOE SLEEVES NATRACURE DOUBLE BUNION GEL SLEEVE W/FOREFOOT (1298-MC CAT/1299-MC CAT) OPEN GEL TOE SEPARATOR SGEL MEDIUM RECOVERY REPLACEMENT WITH MET RISE ADHESIVE SGEL METATARSAL SHAPED PADS BLUEPOINT GEL HEEL CUPS SIZE 2-5 HOT/COLD KNEE WRAP M2GEL ALL GELL HALLUX TOE BUNION GUARD SGEL COMFORT GEL SKIN DRESS BUNION RELIEF SLEEVE WITH GEL METATARSAL PAD SGEL METATARSAL WRAP TOE WRAP 2.5" GEL DISK W/ADHESIVE-MGEL DD SPUR CUP-SMALL M/SOFT DURO GELSMART TOE SPREADER WITH FABRIC LARGE (PAIR) M2GEL ALL GEL TOE SPREADER W/TOE LOOP NATRACURE GEL METATARSAL WRAP (LG/XLG) PLANTAR FASCIA ARCH SLEEVE SGEL MEDUIM RECOVERY WEDGE CENTER SOFT SPOT THREE LOOP HAMMERTOE CORR BLUEPOINT FULL LENGTH GEL INSOLES SIZE 7-8 CTZ ADVANCED TOE SPREADER GEL ARCH FIXER MICROFIBER NECK SLEEVE NATRACURE GEL MOISTURIZING GLOVES (DAY/NIGHT) BLACK SGEL POSTED HEEL WEDGE SOFT SPUR SPOT ADHESIVE SGEL ROUND PADS BLUEPOINT GEL HEEL CUPS SIZE 9+ M2GEL SANDAL SPREADER SGEL COMFORT GELSKIN ARCH BAND TWO IN ONE BALL OF FOOT PROTECTOR AQUA GEL GLOVES BLUEPOINT HEEL WEDGE W SOFT SPUR SIZE 6-8 M2GEL ALL GEL 5TH DIGIT TOE BUNION GUARD MGEL COMFORT GEL FOREFOOT PROTECTOR TGEL FOREFOOT RELIEF PAD UGEL FLEXIBLE SELF ADHESIVE DOTS ADHESIVE SGEL OVAL PADS BLUEPOINT GEL HEEL CUPS SIZE 6-8 INTENSE HYDRATING GEL BOOTIES M2GEL BUNION TOE SPREADER SGEL COMFORT GEL SKIN THIN FOREFOOT CUSHION TWO IN ONE BALL FOOT PROTECTOR BLUEPOINT HEEL WEDGE W SOFT CENTRE SIZE 6-8 BLUEPOINT POSTED HEEL WEDGE SIZE 2-5 ELBOW SLEEVES MGEL ACHILLES/DORSUM PROTECTION SLEEVE MGEL TOE SPREADER UNIVERSAL WRAP BLUEPOINT HIGH HEEL W MET RISE (AM COVER) SIZE 6-8 CTZ TOE CREST DOUBLE LOOP TOE CORRECTOR MGEL COMFORT GELSKIN THIN FOREFOOT PAD MOISTURIZING VENTED HEEL SLV. UNIV TOE RELIEF W/LOOPTEK BLUEPOINT HEEL WEDGE W REM SPUR SIZE 9+ BLUEPOINT LOW PROFILE HEEL WAFFLE SIZE 6-8 M2GEL TOE/FINGER CAP MGEL HEEL-ELBOW SLIP OVER UGEL BUNION BUTTON WITH COVER UNIVERSAL TOE CREST (UNDER TOE CREST) BIG TOE BUNION GUARD VALUE PACK BLUEPOINT HIGH HEEL W MET PAD SIZE 2-5 PAIR DOUBLE BUNION MET SLEEVE MGEL COMFORT GEL SKIN BUNION RELIEF SLEEVE - THIN DRESS UGEL SANDAL SOLE BLUEPOINT FULL LENGTH GEL INSOLES SIZE 10+ BLUEPOINT HEEL WEDGE W SOFT CENTRE SIZE 9+ BLUEPOINT POSTED HEEL WEDGE SIZE 6-8 FLEXIBLE BALL OF FOOT CUSHION MGEL TOE SPREADER WITH RIBBED FABRIC LOOP UNIVERSAL WRAP 20" STRAP BLUEPOINT FULL LENGTH GEL INSOLES SIZE 3-4 BLUEPOINT POSTED HEEL WEDGE SIZE 9+ FLEXIBLE HEEL CUSHION-ONE SIZE MGEL UNIVERSAL MET STRAP (UMS) BLUEPOINT FULL LENGTH GEL INSOLES SIZE 9-10 CTZ BUNION TOE SPREADER-ONE SZ GEL ARCH SLEEVE INTENSE HYDRATING GEL GLOVES MOIST HEAT LONG LASTING SHIELD VENTED HEEL SLEEVE-LARGE GREY NATRACURE INTENSE MOISTURIZING GEL SOCKS SGEL POSTED HEEL WEDGE WITH ARCH SUPPORT SOFT SPUR SPOT BLUEPOINT HEEL WEDGE W REM SPUR SIZE 6-8 M2GEL TOE SEPERATORS MGEL GEL PAD WITH HOOK BACKING SGEL HEEL WEDGE - TRADITIONAL DESIGN WITH REMOVABLE SPUR UGEL BALL OF FOOT NEVER SLIP UNIVERSAL COLD WRAP W/2 GEL PACKS SGEL 3/4 LENGTH THIN DRESS INSOLE WITH METATARSAL RISE ALL GEL FOOTIE GEL PAD WITH TOE LOOP LAVENDER GEL BOOTIES NATRACURE PLANTAR FASCITIS SOCKS - COMPRESSION (600-02 CAT/600-03 CAT/600-04 CAT 600-05 CAT) SILICA BEAD EYE MASK BLUEPOINT HEEL WEDGE W REM SPUR SIZE 2-5 M2GEL TOE CRESTS SGEL GEL ARCH WRAP UGEL ARCH PAD NEVER SLIP UNIVERSAL COLD WRAP 10"X5" ALL GEL TOE/FINGER RINGS BLUEPOINT HEEL WEDGE W SOFT SPUR SIZE 2-5 M2 GEL METATARSAL PAD WITH TOE LOOP MGEL BLUE PALM PAD STAY PUT ALL-GEL TOE SEPERATOR WITH LOOP UGEL FLEXIBLE HEEL CUSHION NEVER SLIP 5 TOE MOISTURIZING BOOTIES BLISTER PREVENTION SOCKS DD SPUR CUP-XL SOFT DURO GELSMART TOE SPREADER WITH FABRIC MEDIUM (PAIR) M2GEL ALL GEL TOE/FINGER TUBE PLANTAR FASCIITIS INSOLE SGEL METATARSAL PAD WITH TOE SEPERATOR THREE LOOP HAMMERTOE RIGHT SGEL 3/4 LENGTH DUAL DUROMETER DEEP INSOLE ADSHESIVE SGEL OVAL PADS CTZ DOUBLE LOOP TOE CORR GEL BUNION GUARD & TOE SPREADER LARGE COLD PACK W/POUCH AND STRAPS NATRACURE INTENSIVE MOISTURIZING GEL HEEL SLEEVE SGEL REPLACEMENT INSOLE WITH SOFT HEEL AND MET ZONES BLUEPOINT 3/4LENGTH GEL INSOLES SIZE 2-5 TGEL DUAL DENSITY INSOLE WITH ARCH SUPPORT AND SOFT TOP COVER CUSTOMIZABLE PLUGS DROP SHIP - BLUEPOINT GEL HEEL CUPS SIZE 9+ GEL TOE SEPERATOR NATRACURE ARCH SUPPORT SLEEVES W/GEL CUSHIONS SGEL MEDIUM RECOVERY HEEL CUP SOFT SPUR SPOT 2.5" GEL DISC-MGEL-6MM DD SPUR CUP-MED-M/SOFT DURO GELSMART M-GEL EXERFEET TOE STRETCHER SINGLE SM/MED NATRACURE GEL METATARSAL SLEEVES (LG/XLG) PINKY TOE BUNION GUARD SGEL MEDIUM-RECOVERY REPLACEMENT WITH MET RAISE TGEL TRADITIONAL DESIGN HEEL WEDGE WITH REMOVABLE SPUR SGEL 3/4 LENGTH THIN DRESS INSOLE ALL GEL 5TH TOE BUNION GUARD GEL MET PAD WITH TOE LOOP LAVENDER BOOTIES/GLOVES SET NATRACURE METATARSAL SLEEVES SGEL ULTRA THIN SELF ADHESIVE GEL SHEETING ALL GEL HEEL SLEEVE-PR LAVENDER MICROFIBER SET HEEL SLEEVE/GLOVES NATRACURE PLANTAR FASCITIS WRAPS (FBA 1291-S CAT 2PK/FBA 1293-S CAT 2PK) SILICONE HEEL CUP UGEL DANCER PAD NEVER SLIP SGEL 3/4 LENGTH THIN DRESS INSOLE WITH SOFT WIDE METATARSAL PAD ALL GEL HALF TOE SLEEVE LAVENDER GEL HEEL SLEEVES (Natracure only) NATRACURE PLANTAR FASCITIS ARCH/HEEL SLEEVES SILICA BEAD SOOTHING EYE MASK SGEL THIN INSOLE WITH SOFT RELIEFS BLUEPOINT HIGH HEEL W MET RISE SIZE 9+ CTZ TOE RELIEF W/TOE LOOP DROP SHIP - BLUEPOINT GEL HEEL CUPS SIZE 6-8 GEL SPORTS CAP NATRACURE ARCH FIXER (SM/MED) SGEL MEDIUM RECOVERY HEEL CUP SOFT CENTER SPOT BLUEPOINT FULL LENGTH GEL INSOLES SIZE 6-7 CGS BUNION W/MET PAD-COV FLEXIBLE SELF ADHESIVE HEEL GRIP MICROFIBER GEL LINED NECK WRAP NATRACURE GEL MOISTURIZING GLOVES (DAY/NIGHT) PROTECTA-GEL; STOMA-GEL; TRACHEOSTO-GEL DD SPUR CUP - SMALL M/SOFT DURO TGEL DUAL DENSITY INSOLE WITH ARCH SUPPORT AND SOFT TOP COVER SGEL LOW PROFILE HEEL - WAFFLE DESIGN SGEL METATARSAL WRAP NATRACURE GEL METATARSAL WRAP (SM/MED) NATRACURE DOUBLE BUNION W/METATARSAL GEL PAD GEL SANDAL SPREADER W/BALL OF FOOT CUSHION (SANDAL SPREADER) NATRACURE GEL METATARSAL WRAP (L/XLG) PLANTAR FASCIA ARCH SLEEVE SILICONE HEEL CUP FLEXIBLE SELF ADH HEEL GRIP SGEL POSTED HEEL WEDGE WITH ARCH SUPPORT SOFT SPUR SPOT UGEL FLEXIBLE SELF ADHESIVE HEEL GRIP SGEL 3/4 LENGTH THIN DRESS INSOLE WITH METATARSAL RISE NATRACURE PLANTAR FASCIITIS ARCH/HEEL SLEEVE MGEL ACHILLES HEEL PROTECTION SLEEVE SGEL HEEL WEDGE - TRADITIONAL DESIGN WITH REMOVABLE SPUR GEL MET PAD WITH TOE LOOP SGEL COMFORT GEL SKIN DRESS BUNION RELIEF WITH GEL METATARSAL PAD M2GEL METATARSAL PAD WITH TOE LOOP DD SPUR CUP - XL SOFT DURO UGEL FLEXIBLE HEEL CUSHION NEVER SLIP SGEL LOW PROFILE HEEL WEDGE SOFT SPUR SPOT SGEL MEDIUM RECOVERY WEDGE CENTER SOFT SPOT TGEL DUAL DENSITY INSOLE WITH TOP COVER NATRACURE PLANTAR FASCIITIS WRAPS (FBA 1291-S CAT 2PK/FBA 1293-S CAT 2PK) SGEL 3/4 LENGTH DUAL DUROMETER DEEP INSOLE SGEL THIN INSOLE WITH SOFT RELIEFS NATRACURE METATARSAL SLEEVES PLANTAR FASCIITIS INSOLE DUAL DENSITY HEEL CUP SGEL 3/4 LENGTH THIN DRESS INSOLE SGEL REPLACEMENT INSOLE WITH SOFT HEEL AND MET ZONES DD SPUR CUP-LG MED SOFT DURO SGEL 3/4 LENGTH THIN DRESS INSOLE WITH SOFT WIDE METATARSAL PAD NATRACURE GEL METATARSAL SLEEVES (LG/XLG) M2GEL ALL GEL HALLUX TOE BUNION GUARD DD SPUR CUP-XXL SOFT DURO FLEXIBLE BALL OF FOOT CUSHION ADHESIVE SGEL METATARSAL SHAPED PADS TWO IN ONE BALL OF FOOT PROTECTOR SGEL MEDIUM RECOVERY HEEL CUP SOFT CENTER SPOT FLEXIBLE HEEL CUSHION -ONE SIZE UGEL FLEXIBLE 3/4 LENGTH DRESS INSOLE NEVER SLIP NATRACURE PLANTAR FASCIITIS SOCKS - COMPRESSION (600-02 CAT/600-03 CAT/600-04 CAT/ 600-05 CAT) NaturCure Hand Therapy Exercise Kit BLUEPOINT FULL LENGTH GEL INSOLES SIZE 3-4 BLUEPOINT 3/4LENGTH GEL INSOLES SIZE 6-8 BLUEPOINT FULL LENGTH GEL INSOLES SIZE 9-10 BLUEPOINT 3/4LENGTH GEL INSOLES SIZE 2-5 BLUEPOINT FULL LENGTH GEL INSOLES SIZE 4-5 BLUEPOINT FULL LENGTH GEL INSOLES SIZE 10+ BLUEPOINT FULL LENGTH GEL INSOLES SIZE 6-7 BLUEPOINT FULL LENGTH GEL INSOLES SIZE 7-8 BLUEPOINT 3/4LENGTH GEL INSOLES SIZE 9+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2005-12-05
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2005-12-05
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2010-12-02
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2005-12-05
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2022-04-19
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2017-03-28
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2018-01-31

Official Correspondent

LAWRENCE KERSEN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

POLYGEL LLC.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005621376. Last updated year: 2026. Please use registration number 3005621376 when referencing this establishment in official correspondence.