Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1221770

FEI Number

1221770

Entity Name

SIGVARIS, INC.

City/State/Country

PEACHTREE CITY, GA, US

Establishment Address

1119 Highway 74 S, PEACHTREE CITY, GA 30269, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

Sigvaris Holding AG (Owner Number: 8031005)

Owner / Operator Contact Address

Sandgrube 29, Appenzell, CH-AI 9050, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cotton Tubular WaveFoam Elasto-Soft Non-Woven Padding Biafoam Biagrip Compressive Biasoft Compression Garments; Chipsleeve, Chipsleeve Custom, Medaform Compression Garments (hand and foot); Compreboot Lite, Standard and Plus, Coolflex Standard Foot Compression Garments; Compreshape and Compreshape Capri Compression Garments (hand and foot); Medahand, Medaglove, Dorsal Pocket Glove Compression Garments (hand and foot); Compreflex Reduce Foot, Medaboot, Secure Glove and Gauntlet Compression Garments; Compreshorts, Compreshorts Capri, Custom and Capri Custom Compression Garments; Compreflex Reduce, Coolflex Standard, Neck & Mandible Pad Compression Garments; Comprevest, Custom only (Chipvest, Chipflow, Legassist, Armassist) Inelastic Wraps, Compreflex Standard, Transition, Complete and Contain

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2016-11-17
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2017-10-27
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2016-11-17
KMO	Binder, Elastic	General Hospital	Class 1	880.5160	2016-11-17
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2016-11-17
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2025-01-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sigvaris Holding AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8031005	SIGVARIS AG	ST GALLEN Sankt Gallen, CH
3004903147	Sigvaris Do Brasil Ind. E Com. LTDA	Jundiai Sao Paulo, BR
3009591331	SIGVARIS France S.A.S.	Saint-Just, Saint-Rambert Auvergne-Rhone-Alpes, FR
3005550595	SIGVARIS Inc. - Holland Facility	Holland, MI, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221770. Last updated year: 2026. Please use registration number 1221770 when referencing this establishment in official correspondence.