FDA Registration
Active
🇺🇸 United States
5 TOE MOISTURIZING BOOTIES
Reg #: 3005621376
·
FEI: 3005621376
·
Expires 2025
Products
1
Proprietary Names
221
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- POLYGEL LLC.
- Registration Number
- 3005621376
- FEI Number
- 3005621376
- Status
- Active
- Expiry Year
- 2025
- 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 |
|---|---|---|---|---|---|
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2005-12-05 |
Proprietary Names
5 TOE MOISTURIZING BOOTIES
DD SPUR CUP-XL SOFT DURO
GELSMART TOE SPREADER WITH FABRIC MEDIUM (PAIR)
NATRACURE GEL METATARSAL WRAP (SM/MED)
PLANTAR FASCIITIS INSOLE
THREE LOOP HAMMERTOE RIGHT
BLUEPOINT HEEL WEDGE W SOFT CENTRE SIZE 9+
BLUEPOINT POSTED HEEL WEDGE SIZE 6-8
MGEL ANKLE PROTECTION SLEEVE
MGEL TOE SPREADER WITH RIBBED FABRIC LOOP
UGEL FLEXIBLE BALL OF FOOT CUSHION NEVER SLIP
UNIVERSAL WRAP 20" STRAP
BLUEPOINT FULL LENGTH GEL INSOLES SIZE 4-5
BLUEPOINT HEEL WEDGE W SOFT SPUR SIZE 6-8
BUNION RELIEF W/APER CUSH
FLEXIBLE SELF ADH. HEEL GRIP
MICROFIBER GEL BOOTIES
ADHESIVE SGEL METATARSAL SHAPED PADS
DD SPUR CUP-XXL SOFT DURO
HOT/COLD KNEE WRAP
M2GEL ALL GELL HALLUX TOE BUNION GUARD
NATRACURE GEL MOISTURIZING GLOVES (DAY/NIGHT)
SGEL COMFORT GEL SKIN DRESS BUNION RELIEF SLEEVE WITH GEL METATARSAL PAD
TOE WRAP
ADSHESIVE SGEL OVAL PADS
BLUEPOINT HEEL WEDGE W REM SPUR SIZE 2-5
LARGE COLD PACK W/POUCH AND STRAPS
M2GEL TOE CRESTS
SGEL GEL ARCH WRAP
UGEL ARCH PAD NEVER SLIP
SGEL THIN INSOLE WITH SOFT RELIEFS
ALL GEL HEEL SLEEVE-PR
DROP SHIP - BLUEPOINT GEL HEEL CUPS SIZE 6-8
GEL SPORTS CAP
LAVENDER MICROFIBER SET HEEL SLEEVE/GLOVES
NATRACURE PLANTAR FASCITIS WRAPS (FBA 1291-S CAT 2PK/FBA 1293-S CAT 2PK)
SGEL MEDIUM RECOVERY HEEL CUP SOFT CENTER SPOT
SILICONE HEEL CUP
BLISTER PREVENTION SOCKS
BLUEPOINT HIGH HEEL W MET PAD SIZE 6-8 PAIR
M2GEL ALL GEL TOE/FINGER TUBE
MGEL COMFORT GEL SKIN DOUBLE BUNION MET SLEEVE
SGEL METATARSAL PAD WITH TOE SEPERATOR
UGEL SANDAL SPREADER
BLUEPOINT HEEL WEDGE W SOFT CENTRE SIZE 2-5
MGEL ACHILLES HEEL PROTECTION SLEEVE
MGEL ROLLED DIGITAL PAD
SGEL LOW PROFILE HEEL WEDGE SOFT SPUR SPOT
UGEL CALLUS PAD NEVER SLIP
UNIVERSAL TOE CRESTS
BIG TOE BUNION GUARD VALUE PACK
BLUEPOINT HIGH HEEL W MET PAD SIZE 2-5 PAIR
M2GEL ALL GEL TOE SPREADER W/TOE LOOP
MGEL COMFORT GEL SKIN BUNION RELIEF SLEEVE - THIN DRESS
SGEL MEDUIM RECOVERY WEDGE CENTER SOFT SPOT
THREE LOOP HAMMERTOE CORR
UGEL SANDAL SOLE
AQUA GEL GLOVES
ELBOW SLEEVES
M2GEL ALL GEL 5TH DIGIT TOE BUNION GUARD
MGEL COMFORT GEL FOREFOOT PROTECTOR
PINK MICROFIBER BOOTIES
SGEL MEDIUM RECOVERY WEDGE CENTER SOFT SPOT
TGEL FOREFOOT RELIEF PAD
UGEL FLEXIBLE SELF ADHESIVE DOTS
ADHESIVE SGEL OVAL PADS
BLUEPOINT GEL HEEL CUPS SIZE 6-8
DOUBLE BUNION MET SLEEVE
INTENSE HYDRATING GEL BOOTIES
M2GEL BUNION TOE SPREADER
SGEL COMFORT GEL SKIN THIN FOREFOOT CUSHION
TWO IN ONE BALL FOOT PROTECTOR
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
BLUEPOINT FULL LENGTH GEL INSOLES SIZE 10+
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
BLUEPOINT HIGH HEEL W MET RISE (AM COVER) SIZE 6-8
MGEL COMFORT GELSKIN THIN FOREFOOT PAD
SGEL POSTED HEEL WEDGE SOFT SPUR SPOT
UNIV TOE RELIEF W/LOOPTEK
BLUEPOINT HEEL WEDGE W REM SPUR SIZE 9+
M2GEL TOE/FINGER CAP
SGEL LOW PROFILE HEEL - WAFFLE DESIGN
UGEL BUNION BUTTON WITH COVER
UNIVERSAL TOE CREST (UNDER TOE CREST)
ALL GEL 5TH TOE BUNION GUARD
BLUEPOINT HEEL WEDGE W REM SPUR SIZE 6-8
M2GEL TOE SEPERATORS
SGEL HEEL WEDGE - TRADITIONAL DESIGN WITH REMOVABLE SPUR
UGEL BALL OF FOOT NEVER SLIP
BLUEPOINT HIGH HEEL W MET RISE SIZE 9+
CTZ TOE RELIEF W/TOE LOOP
MGEL GEL PAD WITH HOOK BACKING
NATRACURE ARCH FIXER (SM/MED)
UNIVERSAL COLD WRAP W/2 GEL PACKS
BLUEPOINT GEL HEEL CUPS SIZE 2-5
BLUEPOINT HIGH HEEL W MET PAD SIZE 9+ PAIR
MGEL COMFORT GELSKIN FOREFOOT CUSHION WITH STRAP
SGEL METATARSAL WRAP
UGEL THONG PROTECTOR WITH MET PAD
BLUEPOINT HEEL WEDGE W SOFT SPUR SIZE 2-5
BLUEPOINT POSTED HEEL WEDGE SIZE 9+
FLEXIBLE HEEL CUSHION-ONE SIZE
MGEL BLUE PALM PAD
MGEL UNIVERSAL MET STRAP (UMS)
VENTED HEEL SLEEVE-LARGE GREY
ADHESIVE SGEL ROUND PADS
BLUEPOINT GEL HEEL CUPS SIZE 9+
INTENSE HYDRATING GEL GLOVES
M2GEL SANDAL SPREADER
SGEL COMFORT GELSKIN ARCH BAND
TWO IN ONE BALL OF FOOT PROTECTOR
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
BLUEPOINT HEEL WEDGE W SOFT CENTRE SIZE 6-8
BLUEPOINT POSTED HEEL WEDGE SIZE 2-5
MGEL ACHILLES/DORSUM PROTECTION SLEEVE
MGEL TOE SPREADER
UGEL DANCER PAD NEVER SLIP
UNIVERSAL WRAP
SGEL 3/4 LENGTH THIN DRESS INSOLE WITH METATARSAL RISE
ALL GEL FOOTIE
CTZ TOE CREST - LEFT
DRESS BUNION RELIEF PAD
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 FULL LENGTH GEL INSOLES SIZE 3-4
2.5" GEL DISK W/ADHESIVE-MGEL
DD SPUR CUP-SMALL M/SOFT DURO
GELSMART TOE SPREADER WITH FABRIC LARGE (PAIR)
NATRACURE GEL METATARSAL WRAP (LG/XLG)
PLANTAR FASCIA ARCH SLEEVE
SGEL 3/4 LENGTH THIN DRESS INSOLE
CTZ TOE CREST
DOUBLE LOOP TOE CORRECTOR
GEL MET PAD WITH TOE LOOP
LAVENDER BOOTIES/GLOVES SET
MOISTURIZING VENTED HEEL SLV.
NATRACURE METATARSAL SLEEVES
SGEL ULTRA THIN SELF ADHESIVE GEL SHEETING
BLUEPOINT FULL LENGTH GEL INSOLES SIZE 6-7
CGS BUNION W/MET PAD-COV
FLEXIBLE SELF ADHESIVE HEEL GRIP
MICROFIBER GEL LINED NECK WRAP
BLUEPOINT 3/4LENGTH GEL INSOLES SIZE 6-8
TGEL DUAL DENSITY INSOLE WITH TOP COVER
BLUEPOINT LOW PROFILE HEEL WAFFLE SIZE 9+
DBL BUNION MET SLEEVE-S/M CGS
GEL TOE SLEEVES
NATRACURE DOUBLE BUNION GEL SLEEVE W/FOREFOOT (1298-MC CAT/1299-MC CAT)
AQUA GEL HEEL SLEEVES (Natracure only)
BLUEPOINT HEEL WEDGE W SOFT SPUR SIZE 9+
FLEXIBLE BALL OF FOOT CUSHION
M2GEL ALL GEL FIFTH DIGIT CORN PAD
MGEL COMFORT GEL SKIN BUNION RELIEF SLEEVE - EXTRA PROTECTION
SGEL 3/4 LENGTH THIN DRESS INSOLE WITH SOFT WIDE METATARSAL PAD
SGEL MEDIUM-RECOVERY REPLACEMENT WITH MET RAISE
TGEL TRADITIONAL DESIGN HEEL WEDGE WITH REMOVABLE SPUR
ALL GEL HALF TOE SLEEVE
UGEL FLEXIBLE SELF ADHESIVE HEEL GRIP
DROP SHIP - BLUEPOINT GEL HEEL CUPS SIZE 2-5
GEL SANDAL SPREADER W/BALL OF FOOT CUHION (sandal spreader)
LAVENDER GEL HEEL SLEEVES (Natracure only)
NATRACURE PLANTAR FASCITIS ARCH/HEEL SLEEVES
SILICA BEAD SOOTHING EYE MASK
BLUEPOINT FULL LENGTH GEL INSOLES SIZE 9-10
CTZ BUNION TOE SPREADER-ONE SZ
DOUBLE LOOP BUNION SPREADER
GEL ARCH SLEEVE
MOIST HEAT LONG LASTING SHIELD
NATRACURE INTENSE MOISTURIZING GEL SOCKS
SGEL 3/4 LENGTH DUAL DUROMETER DEEP INSOLE
CTZ DOUBLE LOOP TOE CORR
DOUBLE LOOP TAILOR BUNION SPDR
GEL BUNION GUARD & TOE SPREADER
MOISTURIZING VENTED HEEL SLEEVE
NATRACURE INTENSIVE MOISTURIZING GEL HEEL SLEEVE
SGEL REPLACEMENT INSOLE WITH SOFT HEEL AND MET ZONES
ALL GEL TOE/FINGER RINGS
DUAL DENSITY HEEL CUP
M2 GEL METATARSAL PAD WITH TOE LOOP
OPEN GEL TOE SEPARATOR
SGEL MEDIUM RECOVERY REPLACEMENT WITH MET RISE
STAY PUT ALL-GEL TOE SEPERATOR WITH LOOP
UGEL FLEXIBLE HEEL CUSHION NEVER SLIP
BLUEPOINT HIGH HEEL W MET RISE SIZE 2-5
MGEL DORSUM PROTECTION SLEEVE
NATRACURE 5-TOE MOISTURIZING GEL SOCKS
SGEL POSTED HEEL WEDGE WITH ARCH SUPPORT SOFT SPUR SPOT
UNIVERAL COLD WRAP
BLUEPOINT 3/4LENGTH GEL INSOLES SIZE 2-5
BLUEPOINT LOW PROFILE HEEL WAFFLE SIZE 6-8
CUSTOMIZABLE PLUGS
GEL TOE SEPERATOR
MGEL HEEL-ELBOW SLIP OVER
NATRACURE ARCH SUPPORT SLEEVES W/GEL CUSHIONS
BLUEPOINT HIGH HEEL W MET RISE SIZE 6-8
CTZ TOE CREST - RIGHT
MGEL DOT WITH PRESSURE SENSITIVE ADHESIVE
NATRACURE ARCH FIXER (L/XLG)
UNIVERSAL COLD WRAP 10"X5"
TGEL DUAL DENSITY INSOLE WITH ARCH SUPPORT AND SOFT TOP COVER
ALL GEL TOE PROTECTOR
DROP SHIP - BLUEPOINT GEL HEEL CUPS SIZE 9+
M2 GEL ALL GEL ADVANCED TOE SPREADER
NATRACURE VENTED MOISTURIZING GEL HEEL SLEEVE
SGEL MEDIUM RECOVERY HEEL CUP SOFT SPUR SPOT
SILICONE HEEL CUP (PROCARE)
PROTECTA-GEL; STOMA-GEL; TRACHEOSTO-GEL
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility