Identity
- Trade Name
- Ballancer Pro Pants (FS) FDA UDI
- Generic Name
- Multi-chamber venous compression system garment, reusable FDA UDI
- Device Name
- The Ballancer Pro Pants (FS) inflatable garment is fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion. FDA UDI
- Model / Reference
- Bal Pants (FS) FDA UDI
- Description
- The Ballancer Pro Pants (FS) inflatable garment is fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion. FDA UDI
Identifiers
- Catalog Number
- L4MP4136C FDA UDI
- Primary DI / UDI-DI
- 07290105876553 FDA UDI
- 510(k) Number
- K013331 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Multi-chamber venous compression system garment, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multi-chamber venous compression system garment, reusable
Ballancer Pro Pants (FS) by MEGO afek Agricultural Cooperative Society Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multi-chamber venous compression system garment, reusable.
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Cleared under the same submission
K013331 also covers:
- Adult Boot # 1A RC-FLS — MEGO afek Agricultural Cooperative Society Ltd
- Adult boot No. 2A RC-FLS — MEGO afek Agricultural Cooperative Society Ltd
- Bal.Pro Pants-Bot.conn w/o print — MEGO afek Agricultural Cooperative Society Ltd
- Ballancer Pro Jacket — MEGO afek Agricultural Cooperative Society Ltd
- Ballancer Pro Pants (FB) — MEGO afek Agricultural Cooperative Society Ltd
- Ballancer Pro Pants-Bot.conn — MEGO afek Agricultural Cooperative Society Ltd
- Ballancer Pro Pants-side inlet — MEGO afek Agricultural Cooperative Society Ltd
- Comfysleeve 2-85 NRC-LEG — MEGO afek Agricultural Cooperative Society Ltd
- Comfysleeve 3-65 NRC-LEG — MEGO afek Agricultural Cooperative Society Ltd
- Comfysleeve 3-75 NRC-LEG — MEGO afek Agricultural Cooperative Society Ltd
- Comfysleeve 3-85 NRC-LEG — MEGO afek Agricultural Cooperative Society Ltd
- Comfysleeve 4-75 NRC-LEG — MEGO afek Agricultural Cooperative Society Ltd
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- MEGO afek Agricultural Cooperative Society Ltd
Sources (1)
- FDA UDI 09ee25a4-1a26-4da8-a91e-4b4d7fcc1e67 36 fields · synced Jun 8, 2026