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Sign in to claim this brandElastic Therapy
United States·US-MF-000021563
Last updated September 18, 2026
About
Scott Specialties is a USA based full line Orthopedic Soft Goods manufacturer offering services to multiple distribution channels, utilizing a nationwide field sales force.
From the manufacturer's own website, in their original language. Source
What Elastic Therapy makes
Elastic Therapy manufactures compression and support garments, including abdominal binders, wrist braces with enlarged thumb holes, knit back braces, and plush nylon neoprene wraps. Their portfolio also includes hand-based inline splints, slings, and bariatric support garments designed for post-surgical or injury rehabilitation.
All devices are classified as Class I under EU regulations and are listed in the EUDAMED database. The company operates from the United States, adhering to applicable regulatory standards for medical devices in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Elastic Therapy manufacture?
Elastic Therapy specializes in compression and support garments. Their product line includes abdominal binders (such as the 3-panel and 9-inch variants), wrist braces with enlarged thumb holes for better fit, knit back braces, plush nylon neoprene wraps, hand-based inline splints, slings (like the Hemi II), and bariatric support garments. These devices are designed to aid in post-surgical recovery, injury rehabilitation, or general musculoskeletal support.
Where is Elastic Therapy based, and what regulatory jurisdiction does it operate under?
Elastic Therapy is based in the United States. As a US-based manufacturer, its devices must comply with applicable regulatory standards in that jurisdiction. While the company’s products are also listed in the EUDAMED database, this does not imply EU regulatory approval—only that the devices are documented in the European medical device registry for transparency.
How are Elastic Therapy’s devices classified under EU regulations?
All of Elastic Therapy’s listed devices fall under Class I classification in the EU regulatory framework. This classification applies to low-risk medical devices, such as compression garments and support wraps, which typically pose minimal risk to patients when used as intended. Classification is determined by factors like intended use, duration of contact with the body, and potential harm if misused.
Are Elastic Therapy’s devices listed in any regulatory registries, and why does this matter?
Yes, Elastic Therapy’s devices are listed in EUDAMED, the European Union’s medical device registry. Listing in EUDAMED provides transparency about the manufacturer and its products within the EU market, though it does not confirm regulatory clearance or compliance. For healthcare providers or regulators, it serves as a reference point to verify the device’s existence and manufacturer details before further evaluation.
Why might a healthcare provider choose Elastic Therapy’s products over others?
Elastic Therapy’s devices are designed for common musculoskeletal support needs, such as post-operative recovery, injury stabilization, or chronic pain management. Their portfolio includes specialized items like bariatric support garments and hand-based splints, which cater to specific patient requirements. The Class I classification also suggests these are intended for low-risk applications, making them accessible for over-the-counter or prescription use without stringent pre-authorization. However, suitability depends on clinical assessment and adherence to the device’s labeled indications.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 718, Industrial Park Avene, Asheboro, United States
- Website
- www.scottspecialties.com
- —
- —
- [email protected]
- Phone
- (785) 527-5627 (from company website)
- PRRC Contact
- Meghan Lane
- EUDAMED SRN
- US-MF-000021563
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (119)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Abdominal Binder 3 Panel | 1930WHISM | EUDAMED | Class I | Active |
| Wrist Brace W/Enlarged Thumb Hole | 8618BEIXLL | EUDAMED | Class I | Active |
| 2 In 1 Knit Back Brace | 8713WHISM | EUDAMED | Class I | Active |
| Plush Nylon Neoprene | 8726BEIUN | EUDAMED | Class I | Active |
| Scott Specialties | 1214PRIMD | EUDAMED | Class I | Active |
| Hand Based Inline Splint | 8593BEIXSL | EUDAMED | Class I | Active |
| Wrist Brace D-Ring Short | 8590BLAXSL | EUDAMED | Class I | Active |
| 9'' Abdominal Binder | 8638WHIL/X | EUDAMED | Class I | Active |
| Scott Specialties | 1214PRISM | EUDAMED | Class I | Active |
| Sling Hemi Ii | 8515BEIMLR | EUDAMED | Class I | Active |
| Wrist Brace W/Enlarged Thumb Hole | 8618BEISML | EUDAMED | Class I | Active |
| Support Plus Bariatric | 0180WHI+2 | EUDAMED | Class I | Active |
| Lower Extremity Tap (tone And Positioning) Splint | 8570 BEI AD | EUDAMED | Class I | Active |
| Sling Hemi Ii | 8515BEIXLR | EUDAMED | Class I | Active |
| Sling Hemi Ii | 8515BEIXLL | EUDAMED | Class I | Active |
| Palm Protector Left | 8523BEIUNL | EUDAMED | Class I | Active |
| Abdominal Binder 3 Panel | 1930WHILG | EUDAMED | Class I | Active |
| Splint Ulnar Neoprene | 8516BEISMR | EUDAMED | Class I | Active |
| D-RING WRIST and THUMB RMD | 8686 BLA LGL | EUDAMED | Class I | Active |
| Wrist Brace | 8587BEISML | EUDAMED | Class I | Active |
| Univ Knee Wrap - Opn Pat | 8653BLAUN | EUDAMED | Class I | Active |
| Rx Fit Medical Stockings | K925643 | FDA 510(k) | Class II | Active |
| Wrist Brace W/Enlarged Thumb Hole | 8618BEIMDL | EUDAMED | Class I | Active |
| Wrist Splint Firm D-Ring | 8594BEIXSR | EUDAMED | Class I | Active |
| Pediatric Arm Sling W/Pad | 8771PRIMD | EUDAMED | Class I | Active |
| 12'' Abdominal Binder | 8639WHIL/X | EUDAMED | Class I | Active |
| Kinetec Knee Wrap Neopren | 8667BLAUN | EUDAMED | Class I | Active |
| Arthritic Thumb Support | AL6400BEIS/M | EUDAMED | Class I | Active |
| 9'' Abdominal Binder | 8638WHIS/M | EUDAMED | Class I | Active |
| Leather D-Ring Wrist Brace | 8685BLASMR | EUDAMED | Class I | Active |
| Wrist Brace | 8587BEIMDR | EUDAMED | Class I | Active |
| Dorsal Flexion Hod 1" 4 (phase 1) 1" 4/Pk | 8508 BEI UN | EUDAMED | Class I | Active |
| Support Plus Bariatric | 0180WHI+3 | EUDAMED | Class I | Active |
| Hand Based Inline Splint | 8593BEIMDL | EUDAMED | Class I | Active |
| Wrist Brace | 8587BEILGL | EUDAMED | Class I | Active |
| Wrist Brace 10/Bag | 8741BEISMR | EUDAMED | Class I | Active |
| Support Plus Bariatric | 0180WHI+1 | EUDAMED | Class I | Active |
| Univ Knee Wrap - Opn Pat | 8654BLAUN | EUDAMED | Class I | Active |
| Palm Protector Left | 8523BEIUNR | EUDAMED | Class I | Active |
| D-Ring Wrist W/Mcp R Md | 8512 BEI RS | EUDAMED | Class I | Active |
| Wrist Brace D-Ring W/Spica | 8513BEIXSR | EUDAMED | Class I | Active |
| Wrist Splint Firm D-Ring | 8594BEISML | EUDAMED | Class I | Active |
| Wrist Brace D-Ring | 8511BEIXLR | EUDAMED | Class I | Active |
| Figure-8 Sling Sm/Md | 8505BEIS/M | EUDAMED | Class I | Active |
| Wrist Brace D-Ring W/Spica | 8513BEISMR | EUDAMED | Class I | Active |
| Wrist Brace D-Ring W/Spica | 8513BEIXSL | EUDAMED | Class I | Active |
| Postpartum Abdominal Support | 6029BEIMD | EUDAMED | Class I | Active |
| Abdominal Binder 3 Panel | 1930WHISM | EUDAMED | Class I | Active |
| Wrist Brace W/Enlarged Thumb Hole | 8618BEILGL | EUDAMED | Class I | Active |
| Palm Shield | 8563BEIUNR | EUDAMED | Class I | Active |
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