FDA Registration
Active
🇺🇸 United States
POLYGEL LLC.
Reg #: 3005621376
·
FEI: 3005621376
·
Expires 2026
Products
9
Proprietary Names
325
Establishment Types
1
Classifications
9
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Registration Details
- Registration Name
- POLYGEL LLC.
- Registration Number
- 3005621376
- FEI Number
- 3005621376
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1 Danforth Drive
- City
- Palmer TWP
- State
- PA
- ZIP
- 18045
- Country
- US
Owner / Operator
- Firm Name
- POLYGEL LLC.
- Operator Number
- 9080190
- Address
- 1 Danforth Dr., --
- City
- Palmer
- State
- PA
- Postal Code
- 18045
- Country
- US
- Correspondent
- LAWRENCE - KERSEN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2005-12-05 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2005-12-05 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2010-12-02 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2005-12-05 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2022-04-19 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2017-03-28 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2018-01-31 |
| Phantom, Anthropomorphic, Radiographic | IXG | Class 1 | Radiology | No | 2018-01-29 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2006-03-30 |
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
GEL SANDAL SPREADER W/BALL OF FOOT CUSHION (SANDAL SPREADER)
NATRACURE GEL METATARSAL WRAP (L/XLG)
FLEXIBLE SELF ADH HEEL GRIP
NATRACURE PLANTAR FASCIITIS ARCH/HEEL SLEEVE
SGEL COMFORT GEL SKIN DRESS BUNION RELIEF WITH GEL METATARSAL PAD
M2GEL METATARSAL PAD WITH TOE LOOP
DD SPUR CUP - XL SOFT DURO
NATRACURE PLANTAR FASCIITIS WRAPS (FBA 1291-S CAT 2PK/FBA 1293-S CAT 2PK)
DD SPUR CUP-LG MED SOFT DURO
M2GEL ALL GEL HALLUX TOE BUNION GUARD
FLEXIBLE HEEL CUSHION -ONE SIZE
NATRACURE PLANTAR FASCIITIS SOCKS - COMPRESSION (600-02 CAT/600-03 CAT/600-04 CAT/ 600-05 CAT)
NaturCure Hand Therapy Exercise Kit
Clearsight
CGS THIN FOREFOOT GEL PAD
ADHESIVE SGEL SHEET - TRIM TO FIT WITH ANTI-MICROBIAL TOP COVER
MGEL BODY PADS - 102MM (4")
GELSMART M-GEL BODY PAD NON ADH SQUARES 10CM
MGEL CARPAL GEL SLEEVE WITH PAD
MGEL CARPAL GEL PADS
SGEL SELF ADHESIVE TRIM TO FIT WITH CLEAR TOP COVER
MGEL BODY DISCS 63.5MM ROUND (2.5")
GELSMART M-GEL BODY PAD ADHESIVE SQUARES 10CM PAIR
UGEL SELF ADHESIVE EXTRA THIN GEL SHEET
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility